CURE ULTRA MALE CATHETER ULTRA M12CRecalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00815947021106), received between Feb 18, 2022 and Dec 8, 2025 — classified as 2 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (31 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749974 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749536 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749530 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN.".

  Patient problems: Pain

  MAUDE report 23749468 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749465 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749463 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749460 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749458 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749457 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749456 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749454 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749451 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749448 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749429 ↗
• MalfunctionDec 8, 2025Product Quality Problem; Product Quality Problem

  END USER REPORTS "HALF OF THEM WERE COMPLETELY DRY LACKING ANY LUBRICANT AT ALL ON THEM. HE SAID HE TRIED TO INSERT SOME LIKE THIS AND THEY WOULD STOP HALFWAY THROUGH URETHRA AS THEY WERE UNLUBRICATED. HE SAID IT HURT HIS URETHRA PUTTING THEM IN BUT ALSO WITH REMOVAL. HE SAID HE TOOK SOME IBUPROFEN AND THE PAIN IN HIS URETHRA WENT AWAY IN ABOUT A HALF HOUR. DENIES ANY BLEEDING OR FURTHER INTERVENTIONS. HE SAID HE THEN APPLIED LUBRICANT TO THE ONES LIKE THIS SO HE COULD GET THEM TO GLIDE IN."

  Patient problems: Pain

  MAUDE report 23749426 ↗
• MalfunctionJul 2, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED ""CATHETERS RECEIVED WAS DRY AND NOT LUBRICATED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384056 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER STATES "THE SIDES OF PACKAGING AROUND CATHETER ARE CURLED IN, CAUSES DIFFICULTY TO OPEN PRODUCT AND CAUSES ONE TO EASILY CONTAMINATE THE PRODUCT UPON REMOVAL POSSIBLY HAVING CONTRIBUTED A UTI A FEW MONTHS AGO. HE SAID PRIOR TO OPENING THESE HE WILL SWAB THE TEAR HERE END WITH AN ALCOHOL SWAB JUST IN CASE UPON REMOVAL IT WILL COME INTO CONTACT WITH THE OUTSIDE LETTUCED EDGE. HE SAID HE HAS HAD UTIS IN THE PAST AND IS SO CAREFUL TO AVOID USE OF THESE BUT SAID HE HAS USED SOME HE MAY HAVE CONTAMINATED INADVERTENTLY. HE FEELS LIKE THIS COULD HAVE POSSIBLY CONTRIBUTED TO A RECENT UTI SEVERAL MONTHS BACK. HE HASN'T HAD A UTI IN A WHILE BUT A FEW MONTHS AGO WHILE HE WAS HAVING THIS ISSUE, HE DEVELOPED A UTI. SYMPTOMS WERE PAIN IN URETHRA, BLADDER AND LOWER BACK AS WELL AS RECTAL PAIN. HE HAD TO GO TO URGENT CARE FOR URINE TESTING AND GET ANTIBIOTICS (NAME UNKNOWN) TO TREAT IT. HAS BEEN DOING WELL UTI FREE NOW." THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS ASSOCIATED WITH THE UTI.

  Patient problems: Urinary Tract Infection

  MAUDE report 19927694 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER STATES "THE SIDES OF PACKAGING AROUND CATHETER ARE CURLED IN, CAUSES DIFFICULTY TO OPEN PRODUCT AND CAUSES ONE TO EASILY CONTAMINATE THE PRODUCT UPON REMOVAL POSSIBLY HAVING CONTRIBUTED A UTI A FEW MONTHS AGO. HE SAID PRIOR TO OPENING THESE HE WILL SWAB THE TEAR HERE END WITH AN ALCOHOL SWAB JUST IN CASE UPON REMOVAL IT WILL COME INTO CONTACT WITH THE OUTSIDE LETTUCE EDGE. HE SAID HE HAS HAD UTIS IN THE PAST AND IS SO CAREFUL TO AVOID USE OF THESE BUT SAID HE HAS USED SOME HE MAY HAVE CONTAMINATED INADVERTENTLY. HE FEELS LIKE THIS COULD HAVE POSSIBLY CONTRIBUTED TO A RECENT UTI SEVERAL MONTHS BACK. HE HASN'T HAD A UTI IN A WHILE BUT A FEW MONTHS AGO WHILE HE WAS HAVING THIS ISSUE, HE DEVELOPED A UTI. SYMPTOMS WERE PAIN IN URETHRA, BLADDER AND LOWER BACK AS WELL AS RECTAL PAIN. HE HAD TO GO TO URGENT CARE FOR URINE TESTING AND GET ANTIBIOTICS (NAME UNKNOWN) TO TREAT IT. HAS BEEN DOING WELL UTI FREE NOW."

  Patient problems: Urinary Tract Infection

  MAUDE report 19927691 ↗
• MalfunctionJun 13, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED, "SAMPLES THAT HE HAD RECEIVED HAD A STRANGE BROWN SUBSTANCE IN IT." NO PHOTO AVAILABLE. LOT NUMBER INFORMATION HAS BEEN CONFIRMED AND NO ADDITIONAL LOT NUMBER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17118237 ↗
• MalfunctionJul 19, 2022Sharp Edges; Sharp Edges

  CONSUMER REPORTS USING QTY 1 ULTRAM12C FROM A SAMPLE PACK, LOT # 210813-3 AND IT "FELT SHARP" IN URETHRA. THIS WAS HIS FIRST TIME TRIALING THIS CATHETER. HE SAID IT FELT SHARP IN HIS URETHRA ALL THE WAY IN THE INSERTION AND REMOVAL OF THE CATHETER. HE HAS NO ALLERGIES HE IS AWARE OF TO LUBRICANT OR OF ANY KIND. HE SAID IT FELT SHARP, "LIKE IT WAS DIGGING INTO HIS URETHRA." NO SHARP EDGES, ABNORMALITIES HE COULD SEE OR NOTED AT ALL WITH THE CATHETER ITSELF. HE MENTIONED HE HAS VERY POOR EYESIGHT AND THIS CATHETER IS COATED IN LUBRICANT WHICH WOULD HAVE MADE IT HARD TO SEE/ NOTATE ABNORMALITIES. HE SAID IT FELT LIKE THE "FRONT LEADING EDGE" UP NEAR THE EYELETS IS WHERE THE FELT THE SHARPNESS MORE. HE SAID THE DISCOMFORT ENDED AS SOON AS THE CATHETER WAS REMOVED. DENIES ANY BLEEDING. NO MEDICAL INTERVENTION SOUGHT. HE HAS NOT HAD THIS FEELING OCCUR WITH OTHER CATHETERS. HE SAID THE LUBRICANT ITSELF FELT DRY AND THICK COMPARED WITH MULTIPLE OTHER CATHETERS HE HAS TRIALED AND HE DID NOT LIKE IT. HE DID PLACE THE CATHETER IN WITH THE COUDE TIP CORRECTLY POINTING UPWARDS, MAKING SURE BLUE LINE WAS UPWARDS.

  Patient problems: Discomfort

  MAUDE report 15051245 ↗
• MalfunctionApr 27, 2022Sharp Edges; Sharp Edges

  END USER REPORTS "THE EYELETS HE NOTED WHAT LOOKED TO BE PLASTIC "SPURS" COMING OFF THE EYELETS. HE FURTHER DESCRIBED IT AS "LIKE SOMEONE TOOK TOE NAIL CLIPPERS AND CUT THE PLASTIC ON IT." HE SAID THIS DEFECT WAS ON ABOUT 30 CATHETERS FROM UNKNOWN LOT # AND UNKNOWN MU. HE HAS SINCE THROWN AWAY THE CATHETERS AS THIS OCCURRED 3-5 WEEKS AGO. HE SAID HE HAD ONLY USED ON HIMSELF ABOUT 3 OR 4 OF THEM BEFORE HE NOTICED THE PROBLEM ON A TOTAL OF ABOUT 30 CATHETERS. HE NOTICED IT BECAUSE THE CATHETER HURT GOING INTO HIS URETHRA AND HE NOTED A "LITTLE BIT OF BLOOD" WHEN PULLING THE CATHETER OUT AND THAT DRIPPED FROM HIS URETHRA EACH OF THESE 3-4 TIMES. HE HELD PRESSURE TO HIS MEATUS WITH TOILET PAPER TO BLOT IT FOR 2-3 MIN AND THEN IT STOPPED. AFTER THIS OCCURRED, HE INSPECTED THE CATHETERS BY WIPING THEM OFF WITH TOILET PAPER AND EVEN THE TOILET PAPER WOULD GET CAUGHT ON THE PLASTIC PARTS HE DESCRIBED AS PLASTIC "SPURS" NEAR THE EYELETS. HE EVEN COULD TELL THEY HAD THIS DEFECT WHEN HE TOOK OUT HIS MAGNIFYING LENS. HE DID NOT SEEK MEDICAL ATTENTION FOR THE BLEEDING THAT OCCURRED. "

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14222126 ↗
• MalfunctionApr 27, 2022Sharp Edges; Sharp Edges

  END USER REPORTS "THE EYELETS HE NOTED WHAT LOOKED TO BE PLASTIC "SPURS" COMING OFF THE EYELETS. HE FURTHER DESCRIBED IT AS "LIKE SOMEONE TOOK TOE NAIL CLIPPERS AND CUT THE PLASTIC ON IT." HE SAID THIS DEFECT WAS ON ABOUT 30 CATHETERS FROM UNKNOWN LOT # AND UNKNOWN MU. HE HAS SINCE THROWN AWAY THE CATHETERS AS THIS OCCURRED 3-5 WEEKS AGO. HE SAID HE HAD ONLY USED ON HIMSELF ABOUT 3 OR 4 OF THEM BEFORE HE NOTICED THE PROBLEM ON A TOTAL OF ABOUT 30 CATHETERS. HE NOTICED IT BECAUSE THE CATHETER HURT GOING INTO HIS URETHRA AND HE NOTED A "LITTLE BIT OF BLOOD" WHEN PULLING THE CATHETER OUT AND THAT DRIPPED FROM HIS URETHRA EACH OF THESE 3-4 TIMES. HE HELD PRESSURE TO HIS MEATUS WITH TOILET PAPER TO BLOT IT FOR 2-3 MIN AND THEN IT STOPPED. AFTER THIS OCCURRED, HE INSPECTED THE CATHETERS BY WIPING THEM OFF WITH TOILET PAPER AND EVEN THE TOILET PAPER WOULD GET CAUGHT ON THE PLASTIC PARTS HE DESCRIBED AS PLASTIC "SPURS" NEAR THE EYELETS. HE EVEN COULD TELL THEY HAD THIS DEFECT WHEN HE TOOK OUT HIS MAGNIFYING LENS. HE DID NOT SEEK MEDICAL ATTENTION FOR THE BLEEDING THAT OCCURRED. "

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14222084 ↗
• MalfunctionApr 27, 2022Sharp Edges; Sharp Edges

  END USER REPORTS "THE EYELETS HE NOTED WHAT LOOKED TO BE PLASTIC "SPURS" COMING OFF THE EYELETS. HE FURTHER DESCRIBED IT AS "LIKE SOMEONE TOOK TOE NAIL CLIPPERS AND CUT THE PLASTIC ON IT." HE SAID THIS DEFECT WAS ON ABOUT 30 CATHETERS FROM UNKNOWN LOT # AND UNKNOWN MU. HE HAS SINCE THROWN AWAY THE CATHETERS AS THIS OCCURRED 3-5 WEEKS AGO. HE SAID HE HAD ONLY USED ON HIMSELF ABOUT 3 OR 4 OF THEM BEFORE HE NOTICED THE PROBLEM ON A TOTAL OF ABOUT 30 CATHETERS. HE NOTICED IT BECAUSE THE CATHETER HURT GOING INTO HIS URETHRA AND HE NOTED A "LITTLE BIT OF BLOOD" WHEN PULLING THE CATHETER OUT AND THAT DRIPPED FROM HIS URETHRA EACH OF THESE 3-4 TIMES. HE HELD PRESSURE TO HIS MEATUS WITH TOILET PAPER TO BLOT IT FOR 2-3 MIN AND THEN IT STOPPED. AFTER THIS OCCURRED, HE INSPECTED THE CATHETERS BY WIPING THEM OFF WITH TOILET PAPER AND EVEN THE TOILET PAPER WOULD GET CAUGHT ON THE PLASTIC PARTS HE DESCRIBED AS PLASTIC "SPURS" NEAR THE EYELETS. HE EVEN COULD TELL THEY HAD THIS DEFECT WHEN HE TOOK OUT HIS MAGNIFYING LENS. HE DID NOT SEEK MEDICAL ATTENTION FOR THE BLEEDING THAT OCCURRED. "

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14222081 ↗
• MalfunctionApr 27, 2022Sharp Edges; Sharp Edges

  END USER REPORTS "THE EYELETS HE NOTED WHAT LOOKED TO BE PLASTIC "SPURS" COMING OFF THE EYELETS. HE FURTHER DESCRIBED IT AS "LIKE SOMEONE TOOK TOE NAIL CLIPPERS AND CUT THE PLASTIC ON IT." HE SAID THIS DEFECT WAS ON ABOUT 30 CATHETERS FROM UNKNOWN LOT # AND UNKNOWN MU. HE HAS SINCE THROWN AWAY THE CATHETERS AS THIS OCCURRED 3-5 WEEKS AGO. HE SAID HE HAD ONLY USED ON HIMSELF ABOUT 3 OR 4 OF THEM BEFORE HE NOTICED THE PROBLEM ON A TOTAL OF ABOUT 30 CATHETERS. HE NOTICED IT BECAUSE THE CATHETER HURT GOING INTO HIS URETHRA AND HE NOTED A "LITTLE BIT OF BLOOD" WHEN PULLING THE CATHETER OUT AND THAT DRIPPED FROM HIS URETHRA EACH OF THESE 3-4 TIMES. HE HELD PRESSURE TO HIS MEATUS WITH TOILET PAPER TO BLOT IT FOR 2-3 MIN AND THEN IT STOPPED. AFTER THIS OCCURRED, HE INSPECTED THE CATHETERS BY WIPING THEM OFF WITH TOILET PAPER AND EVEN THE TOILET PAPER WOULD GET CAUGHT ON THE PLASTIC PARTS HE DESCRIBED AS PLASTIC "SPURS" NEAR THE EYELETS. HE EVEN COULD TELL THEY HAD THIS DEFECT WHEN HE TOOK OUT HIS MAGNIFYING LENS. HE DID NOT SEEK MEDICAL ATTENTION FOR THE BLEEDING THAT OCCURRED. "

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14222079 ↗
• MalfunctionApr 27, 2022Sharp Edges; Sharp Edges

  END USER REPORTS "THE EYELETS HE NOTED WHAT LOOKED TO BE PLASTIC "SPURS" COMING OFF THE EYELETS. HE FURTHER DESCRIBED IT AS "LIKE SOMEONE TOOK TOE NAIL CLIPPERS AND CUT THE PLASTIC ON IT." HE SAID THIS DEFECT WAS ON ABOUT 30 CATHETERS FROM UNKNOWN LOT # AND UNKNOWN MU. HE HAS SINCE THROWN AWAY THE CATHETERS AS THIS OCCURRED 3-5 WEEKS AGO. HE SAID HE HAD ONLY USED ON HIMSELF ABOUT 3 OR 4 OF THEM BEFORE HE NOTICED THE PROBLEM ON A TOTAL OF ABOUT 30 CATHETERS. HE NOTICED IT BECAUSE THE CATHETER HURT GOING INTO HIS URETHRA AND HE NOTED A "LITTLE BIT OF BLOOD" WHEN PULLING THE CATHETER OUT AND THAT DRIPPED FROM HIS URETHRA EACH OF THESE 3-4 TIMES. HE HELD PRESSURE TO HIS MEATUS WITH TOILET PAPER TO BLOT IT FOR 2-3 MIN AND THEN IT STOPPED. AFTER THIS OCCURRED, HE INSPECTED THE CATHETERS BY WIPING THEM OFF WITH TOILET PAPER AND EVEN THE TOILET PAPER WOULD GET CAUGHT ON THE PLASTIC PARTS HE DESCRIBED AS PLASTIC "SPURS" NEAR THE EYELETS. HE EVEN COULD TELL THEY HAD THIS DEFECT WHEN HE TOOK OUT HIS MAGNIFYING LENS. HE DID NOT SEEK MEDICAL ATTENTION FOR THE BLEEDING THAT OCCURRED. "

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14222043 ↗