CURE CATHETER M16CRecalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 00815947020093), received between Sep 5, 2019 and Jun 3, 2026 — classified as 3 injuries, 92 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (92 reports).

1 other recall cover devices cleared under the same FDA submission (K072539); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 95 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  (B)(6) YEAR OLD END USER REPORTS HE HAS HAD "INFECTIONS IN THE BLADDER" IN HIS PAST AND HIS DOCTOR HAS NEEDED TO GIVE HIM MEDICINE FOR AT TIME BUT DOESN'T KNOW IF POSSIBLY THIS COULD BE CAUSED BY USING CATHETERS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 25378462 ↗
• MalfunctionApr 29, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14251039 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243796 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243787 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243637 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243629 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243622 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243422 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243415 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243387 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243379 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243372 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243370 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN JULY/AUG 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTIO

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243364 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243256 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243249 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243246 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243237 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243229 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN JULY/AUG 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTIO

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243222 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243209 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243201 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENT

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243142 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14243136 ↗
• MalfunctionApr 28, 2022Sharp Edges; Sharp Edges

  CONSUMER STATES THE CATHETERS M16C FEEL LIKE SOME OF THEM HAVE A "BUR" ON THE END OF THEM THAT SCRATCH HIM AT THE VERY TIP WHEN THEY ENTER HIS BLADDER AND SOMETIMES CAUSE HIM TO HAVE MINOR BLEEDING AFTER. HE HAS USED THESE CATHETERS SINCE HE STARTED CATHING IN (B)(6) 2017 AND FEELS THE PROBLEM IS GETTING WORSE. HE THINKS IT IS A QUALITY CONTROL ISSUE. AT TIMES, HE HAS SMALL QUANTITIES OF BLOOD AS WELL THAT CAN BE VISIBLE AS HE RETRACTED THE CATHETER AND SOMETIMES HE NOTES IT WHEN HE CLEANS HIS MEATUS OR EVEN A SHORT TIME AFTER. HE SAID IT IS NOT A LOT OF BLOOD AND NOT NOTED IN HIS URINE. HE IS NOT ON BLOOD THINNERS. HE NOTES NO ABNORMALITY WITH THE CATHETER ITSELF VISIBLY PRIOR TO CATHING. HE SAID HE SEES NO ABNORMALITY WITH THE EYELETS. HE DOES SAY THAT HE SOMETIMES PUTS THE COUDE TIP IN HIS MEATUS TO THE RIGHT/ LEFT OR DOWN, NOT ALWAYS UPWARDS. I RELAYED TO HIM THE PROPER WAY TO PLACE A COUDE TIP IS UPWARDS AND HE SAID HE WILL TRY THAT. HE HAS NOT SEEN HIS UROLOGIST IN A LONG TIME OVER A YEAR STATING THEY JUST WANT TO GIVE HIM MEDICATIONS AND HE CAN TEACH HIS DOCTOR ABOUT HIS CONDITION. HE SAID HE HAS AN APPOINTMENT NEXT WEEK WITH HIS PCP. HE STARTED CATHING BECAUSE OF RETENTION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14242991 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072539. One submission often covers many models, so check the product and lot details in each record.

• Z-0004-2013 · Sep 19, 2012 · Terminated
  Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (