CURE CATHETER HM12Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00815947020307), received between Dec 7, 2018 and Feb 19, 2026 — classified as 7 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (21 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Sharp Edges

  IT WAS REPORTED "CATHETER SHAFTS ARE NOT SMOOTH IN AREAS, THEY HAVE KINKS AND "CRUSTINESS" ON CATHETERS - CAUSED LIGHT BLEEDING WITH USE IN PAST." CONSUMER REPORTS "CATHING FOR RETENTION FOR MANY YEARS, PREVIOUSLY USING THE HM12C BUT THEM SWITCHED TO THE HM12 A FEW MONTHS AGO AS EASIER TO GET THROUGH HIS ANATOMY. HE SAID THIS ISSUE STARTED 2 MONTHS AGO WITH THIS PRODUCT. HE SAID HE WILL PREP THE CATHETERS AS USUAL BY BURSTING THE WATER SACHET AND THEN ENSURING THE WATER GETS ALL OVER THE CATHETER PRIOR TO OPENING THEM. WHEN HE REMOVES THEM FROM THE PACKAGING HE ENSURES THAT THE CATHETERS ARE SMOOTH BY RUNNING UP AND DOWN THE CATHETER THE SLEEVE. HE SAID ON SOME HE WILL FEEL SOME "CRUSTY STUFF" ALONG THE SHAFT AROUND THE MIDDLE OF THE CATHETERS AND CAN FEEL LIKE A LITTLE KINK AT TIMES AS WELL. NOW HE WILL NOT USE THESE IF HE FINDS THIS CONCERN. HE NOTES SOME HAVE TIPS THAT ARE STUCK TO THE PACKAGING ON THESE BUT NOT A BIG ISSUE AS THEY ARE ABLE TO COME LOOSE EASILY AND UNSURE IF THAT COULD BE RELATED TO THIS CONCERN AS WELL. IN THE PAST HE TRIED TO USE A FEW LIKE THIS AND NOTED THEY WERE UNCOMFORTABLE DUE TO THE DEFECT AND HAD VERY LIGHT BLEEDING IN HIS URINE DRAINAGE BUT IT STOPPED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24387494 ↗
• MalfunctionFeb 19, 2026Sharp Edges

  IT WAS REPORTED "CATHETER SHAFTS ARE NOT SMOOTH IN AREAS, THEY HAVE KINKS AND "CRUSTINESS" ON CATHETERS - CAUSED LIGHT BLEEDING WITH USE IN PAST." CONSUMER REPORTS "CATHING FOR RETENTION FOR MANY YEARS, PREVIOUSLY USING THE HM12C BUT THEM SWITCHED TO THE HM12 A FEW MONTHS AGO AS EASIER TO GET THROUGH HIS ANATOMY. HE SAID THIS ISSUE STARTED 2 MONTHS AGO WITH THIS PRODUCT. HE SAID HE WILL PREP THE CATHETERS AS USUAL BY BURSTING THE WATER SACHET AND THEN ENSURING THE WATER GETS ALL OVER THE CATHETER PRIOR TO OPENING THEM. WHEN HE REMOVES THEM FROM THE PACKAGING HE ENSURES THAT THE CATHETERS ARE SMOOTH BY RUNNING UP AND DOWN THE CATHETER THE SLEEVE. HE SAID ON SOME HE WILL FEEL SOME "CRUSTY STUFF" ALONG THE SHAFT AROUND THE MIDDLE OF THE CATHETERS AND CAN FEEL LIKE A LITTLE KINK AT TIMES AS WELL. NOW HE WILL NOT USE THESE IF HE FINDS THIS CONCERN. HE NOTES SOME HAVE TIPS THAT ARE STUCK TO THE PACKAGING ON THESE BUT NOT A BIG ISSUE AS THEY ARE ABLE TO COME LOOSE EASILY AND UNSURE IF THAT COULD BE RELATED TO THIS CONCERN AS WELL. IN THE PAST HE TRIED TO USE A FEW LIKE THIS AND NOTED THEY WERE UNCOMFORTABLE DUE TO THE DEFECT AND HAD VERY LIGHT BLEEDING IN HIS URINE DRAINAGE BUT IT STOPPED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24387493 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS HE HAS HAD 4 UTIS IN THE LAST 7 MONTHS. HIS UTI HISTORY IS AS FOLLOWS. PRIOR TO THIS RECENT UTI HISTORY, HE HAS NOT HAD ANY UTIS IN THE PAST 7 PRIOR YEARS. IN (B)(6) 2025 HE HAD PAIN AT THE DISTAL PART OF HIS PENIS SO HIS MD PLACED ON HIM ON ANTIBIOTICS FOR SUSPECTED URETHRITIS AND THIS CLEARED UP HIS SYMPTOMS. ABOUT A MONTH LATER ON (B)(6) HE STARTED HAVING CLOUDY URINE, FREQUENCY AND LEAKAGE SO THEY DID A URINE TEST AND A BACTERIA CALLED MSSA (METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS) WAS FOUND IN HIS URINE AND HE WAS PLACED ON MACROBID WHICH HELPED HIS SYMPTOMS. HE WAS UTI FREE FOR 4 MONTHS BUT AT THE END OF MAY (WHEN HE WAS USING THESE DEFECTED CATHETERS) ON (B)(6) HIS PRIOR UTI SYMPTOMS CAME BACK AND HE WAS FOUND TO HAVE 10-25 K COLONY COUNT OF STAPH AUREUS IN HIS URINE CULTURE AND HE WAS GIVEN 10 DAYS OF MACROBID WHICH CLEARED HIS SYMPTOMS UP UNTIL (B)(6) WHEN HE STARTED TO HAVE SYMPTOMS AGAIN AND HE WAS FOUND TO HAVE 50K COLONY COUNT OF MSSA AND 20 K OF STREP PNEUMONIAE WHICH WAS TREATED WITH LEVOFLOXACIN FOR 5 DAYS WHICH HE SAID HELPED HIS SYMPTOMS. HE SAID HIS MD THEN WANTED HIM TO START ON A 30 DAY ROUND OF MACROBID AS HE THOUGHT POSSIBILITY THIS BAC

  Patient problems: Urinary Tract Infection

  MAUDE report 22733593 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS HE HAS HAD 4 UTIS IN THE LAST 7 MONTHS. HIS UTI HISTORY IS AS FOLLOWS. PRIOR TO THIS RECENT UTI HISTORY, HE HAS NOT HAD ANY UTIS IN THE PAST 7 PRIOR YEARS. IN DEC 24¿ ¿ JAN 2025 HE HAD PAIN AT THE DISTAL PART OF HIS PENIS SO HIS MD PLACED ON HIM ON ANTIBIOTICS FOR SUSPECTED URETHRITIS AND THIS CLEARED UP HIS SYMPTOMS. ABOUT A MONTH LATER ON (B)(6) HE STARTED HAVING CLOUDY URINE, FREQUENCY AND LEAKAGE SO THEY DID A URINE TEST AND A BACTERIA CALLED MSSA (METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS) WAS FOUND IN HIS URINE AND HE WAS PLACED ON MACROBID WHICH HELPED HIS SYMPTOMS. HE WAS UTI FREE FOR 4 MONTHS BUT AT THE END OF MAY (WHEN HE WAS USING THESE DEFECTED CATHETERS) ON (B)(6) HIS PRIOR UTI SYMPTOMS CAME BACK AND HE WAS FOUND TO HAVE 10-25 K COLONY COUNT OF STAPH AUREUS IN HIS URINE CULTURE AND HE WAS GIVEN 10 DAYS OF MACROBID WHICH CLEARED HIS SYMPTOMS UP UNTIL ON (B)(6) WHEN HE STARTED TO HAVE SYMPTOMS AGAIN AND HE WAS FOUND TO HAVE 50K COLONY COUNT OF MSSA AND 20 K OF STREP PNEUMONIAE WHICH WAS TREATED WITH LEVOFLOXACIN FOR 5 DAYS WHICH HE SAID HELPED HIS SYMPTOMS. HE SAID HIS MD THEN WANTED HIM TO START ON A 30 DAY ROUND OF MACROBID AS HE THOUGHT POSSIBILIT

  Patient problems: Urinary Tract Infection

  MAUDE report 22733589 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Urinary Tract Infection

  MAUDE report 22733024 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  END USER REPORTS HE HAS HAD 4 UTIS IN THE LAST 7 MONTHS. HIS UTI HISTORY IS AS FOLLOWS. PRIOR TO THIS RECENT UTI HISTORY, HE HAS NOT HAD ANY UTIS IN THE PAST 7 PRIOR YEARS. IN (B)(6) 2024 ¿ (B)(6) 2025 HE HAD PAIN AT THE DISTAL PART OF HIS PENIS SO HIS MD PLACED ON HIM ON ANTIBIOTICS FOR SUSPECTED URETHRITIS AND THIS CLEARED UP HIS SYMPTOMS. ABOUT A MONTH LATER ON (B)(6) HE STARTED HAVING CLOUDY URINE, FREQUENCY AND LEAKAGE SO THEY DID A URINE TEST AND A BACTERIA CALLED MSSA (METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS) WAS FOUND IN HIS URINE AND HE WAS PLACED ON MACROBID WHICH HELPED HIS SYMPTOMS. HE WAS UTI FREE FOR 4 MONTHS BUT AT THE END OF (B)(6) (WHEN HE WAS USING THESE DEFECTED CATHETERS) ON (B)(6) HIS PRIOR UTI SYMPTOMS CAME BACK AND HE WAS FOUND TO HAVE 10-25 K COLONY COUNT OF STAPH AUREUS IN HIS URINE CULTURE AND HE WAS GIVEN 10 DAYS OF MACROBID WHICH CLEARED HIS SYMPTOMS UP UNTIL (B)(6) WHEN HE STARTED TO HAVE SYMPTOMS AGAIN AND HE WAS FOUND TO HAVE 50K COLONY COUNT OF MSSA AND 20 K OF STREP PNEUMONIAE WHICH WAS TREATED WITH LEVOFLOXACIN FOR 5 DAYS WHICH HE SAID HELPED HIS SYMPTOMS. HE SAID HIS MD THEN WANTED HIM TO START ON A 30 DAY ROUND OF MACROBID AS HE THOUGHT POS

  Patient problems: Urinary Tract Infection

  MAUDE report 22733017 ↗
• MalfunctionMay 13, 2024Sharp Edges; Sharp Edges

  END USER REPORTS "ROUGH, UNPOLISHED EYELETS" FOUND ON THE HM12 CATHETERS. HE SAID THE "EYELETS STILL DON'T LOOK AS POLISHED WHEN COMPARING TO OTHERS THAT ARE SMOOTH. HE SAID HE HAS BEEN USING A VERY STRONG MAGNIFICATION LENS OR A MICROSCOPE HE HAS WITH AN LED LIGHT TO CHECK THEM THROUGH THE PACKAGING" EVER SINCE HIS BLEEDING EVENTS DESCRIBED IN A PREVIOUS CASE AND WILL NOT USE ANY THAT DON'T LOOK SMOOTH TO HIM. HE HAS BEEN SETTING THESE ASIDE AND NOT USING THEM. HE SAID 2 LOOK WORSE THAN THE OTHERS HE HAS COLLECTED AS THEY HAVE "LITTLE PLASTIC PIECES" STICKING OUT FROM EYELETS - HE LABELED THOSE WITH A "W" ON THE PACKAGING FOR WORSE. NO HARM WAS REPORTED FOR THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296937 ↗
• MalfunctionMay 13, 2024Sharp Edges; Sharp Edges

  END USER REPORTS "ROUGH, UNPOLISHED EYELETS" FOUND ON THE HM12 CATHETERS. HE SAID THE "EYELETS STILL DON'T LOOK AS POLISHED WHEN COMPARING TO OTHERS THAT ARE SMOOTH. HE SAID HE HAS BEEN USING A VERY STRONG MAGNIFICATION LENS OR A MICROSCOPE HE HAS WITH AN LED LIGHT TO CHECK THEM THROUGH THE PACKAGING" EVER SINCE HIS BLEEDING EVENTS DESCRIBED IN A PREVIOUS CASE AND WILL NOT USE ANY THAT DON'T LOOK SMOOTH TO HIM. HE HAS BEEN SETTING THESE ASIDE AND NOT USING THEM. HE SAID 2 LOOK WORSE THAN THE OTHERS HE HAS COLLECTED AS THEY HAVE "LITTLE PLASTIC PIECES" STICKING OUT FROM EYELETS - HE LABELED THOSE WITH A "W" ON THE PACKAGING FOR WORSE. NO HARM WAS REPORTED FOR THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296704 ↗
• MalfunctionMay 13, 2024Sharp Edges; Sharp Edges

  END USER REPORTS "ROUGH, UNPOLISHED EYELETS" FOUND ON THE HM12 CATHETERS. HE SAID THE "EYELETS STILL DON'T LOOK AS POLISHED WHEN COMPARING TO OTHERS THAT ARE SMOOTH. HE SAID HE HAS BEEN USING A VERY STRONG MAGNIFICATION LENS OR A MICROSCOPE HE HAS WITH AN LED LIGHT TO CHECK THEM THROUGH THE PACKAGING" EVER SINCE HIS BLEEDING EVENTS DESCRIBED IN A PREVIOUS CASE AND WILL NOT USE ANY THAT DON'T LOOK SMOOTH TO HIM. HE HAS BEEN SETTING THESE ASIDE AND NOT USING THEM. HE SAID 2 LOOK WORSE THAN THE OTHERS HE HAS COLLECTED AS THEY HAVE "LITTLE PLASTIC PIECES" STICKING OUT FROM EYELETS - HE LABELED THOSE WITH A "W" ON THE PACKAGING FOR WORSE. NO HARM WAS REPORTED FOR THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296703 ↗
• MalfunctionMay 13, 2024Sharp Edges; Sharp Edges

  END USER REPORTS "ROUGH, UNPOLISHED EYELETS" FOUND ON THE HM12 CATHETERS. HE SAID THE "EYELETS STILL DON'T LOOK AS POLISHED WHEN COMPARING TO OTHERS THAT ARE SMOOTH. HE SAID HE HAS BEEN USING A VERY STRONG MAGNIFICATION LENS OR A MICROSCOPE HE HAS WITH AN LED LIGHT TO CHECK THEM THROUGH THE PACKAGING" EVER SINCE HIS BLEEDING EVENTS DESCRIBED IN A PREVIOUS CASE AND WILL NOT USE ANY THAT DON'T LOOK SMOOTH TO HIM. HE HAS BEEN SETTING THESE ASIDE AND NOT USING THEM. HE SAID 2 LOOK WORSE THAN THE OTHERS HE HAS COLLECTED AS THEY HAVE "LITTLE PLASTIC PIECES" STICKING OUT FROM EYELETS - HE LABELED THOSE WITH A "W" ON THE PACKAGING FOR WORSE. NO HARM WAS REPORTED FOR THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296702 ↗
• MalfunctionMay 13, 2024Sharp Edges; Sharp Edges

  END USER REPORTS "ROUGH, UNPOLISHED EYELETS" FOUND ON THE HM12 CATHETERS. HE SAID THE "EYELETS STILL DON'T LOOK AS POLISHED WHEN COMPARING TO OTHERS THAT ARE SMOOTH. HE SAID HE HAS BEEN USING A VERY STRONG MAGNIFICATION LENS OR A MICROSCOPE HE HAS WITH AN LED LIGHT TO CHECK THEM THROUGH THE PACKAGING" EVER SINCE HIS BLEEDING EVENTS DESCRIBED IN A PREVIOUS CASE AND WILL NOT USE ANY THAT DON'T LOOK SMOOTH TO HIM. HE HAS BEEN SETTING THESE ASIDE AND NOT USING THEM. HE SAID 2 LOOK WORSE THAN THE OTHERS HE HAS COLLECTED AS THEY HAVE "LITTLE PLASTIC PIECES" STICKING OUT FROM EYELETS - HE LABELED THOSE WITH A "W" ON THE PACKAGING FOR WORSE. NO HARM WAS REPORTED FOR THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296701 ↗
• MalfunctionMay 13, 2024Sharp Edges; Sharp Edges

  END USER REPORTS "ROUGH, UNPOLISHED EYELETS" FOUND ON THE HM12 CATHETERS. HE SAID THE "EYELETS STILL DON'T LOOK AS POLISHED WHEN COMPARING TO OTHERS THAT ARE SMOOTH. HE SAID HE HAS BEEN USING A VERY STRONG MAGNIFICATION LENS OR A MICROSCOPE HE HAS WITH AN LED LIGHT TO CHECK THEM THROUGH THE PACKAGING" EVER SINCE HIS BLEEDING EVENTS DESCRIBED IN A PREVIOUS CASE AND WILL NOT USE ANY THAT DON'T LOOK SMOOTH TO HIM. HE HAS BEEN SETTING THESE ASIDE AND NOT USING THEM. HE SAID 2 LOOK WORSE THAN THE OTHERS HE HAS COLLECTED AS THEY HAVE "LITTLE PLASTIC PIECES" STICKING OUT FROM EYELETS - HE LABELED THOSE WITH A "W" ON THE PACKAGING FOR WORSE. NO HARM WAS REPORTED FOR THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296700 ↗
• MalfunctionMay 13, 2024Sharp Edges; Sharp Edges

  END USER REPORTS "ROUGH, UNPOLISHED EYELETS" FOUND ON THE HM12 CATHETERS. HE SAID THE "EYELETS STILL DON'T LOOK AS POLISHED WHEN COMPARING TO OTHERS THAT ARE SMOOTH. HE SAID HE HAS BEEN USING A VERY STRONG MAGNIFICATION LENS OR A MICROSCOPE HE HAS WITH AN LED LIGHT TO CHECK THEM THROUGH THE PACKAGING" EVER SINCE HIS BLEEDING EVENTS DESCRIBED IN A PREVIOUS CASE AND WILL NOT USE ANY THAT DON'T LOOK SMOOTH TO HIM. HE HAS BEEN SETTING THESE ASIDE AND NOT USING THEM. HE SAID 2 LOOK WORSE THAN THE OTHERS HE HAS COLLECTED AS THEY HAVE "LITTLE PLASTIC PIECES" STICKING OUT FROM EYELETS - HE LABELED THOSE WITH A "W" ON THE PACKAGING FOR WORSE. NO HARM WAS REPORTED FOR THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296699 ↗
• MalfunctionMay 13, 2024Sharp Edges; Sharp Edges

  END USER REPORTS "ROUGH, UNPOLISHED EYELETS" FOUND ON THE HM12 CATHETERS. HE SAID THE "EYELETS STILL DON'T LOOK AS POLISHED WHEN COMPARING TO OTHERS THAT ARE SMOOTH. HE SAID HE HAS BEEN USING A VERY STRONG MAGNIFICATION LENS OR A MICROSCOPE HE HAS WITH AN LED LIGHT TO CHECK THEM THROUGH THE PACKAGING" EVER SINCE HIS BLEEDING EVENTS DESCRIBED IN A PREVIOUS CASE AND WILL NOT USE ANY THAT DON'T LOOK SMOOTH TO HIM. HE HAS BEEN SETTING THESE ASIDE AND NOT USING THEM. HE SAID 2 LOOK WORSE THAN THE OTHERS HE HAS COLLECTED AS THEY HAVE "LITTLE PLASTIC PIECES" STICKING OUT FROM EYELETS - HE LABELED THOSE WITH A "W" ON THE PACKAGING FOR WORSE. NO HARM WAS REPORTED FOR THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296698 ↗
• MalfunctionMay 13, 2024Sharp Edges; Sharp Edges

  END USER REPORTS "ROUGH, UNPOLISHED EYELETS" FOUND ON THE HM12 CATHETERS. HE SAID THE "EYELETS STILL DON'T LOOK AS POLISHED WHEN COMPARING TO OTHERS THAT ARE SMOOTH. HE SAID HE HAS BEEN USING A VERY STRONG MAGNIFICATION LENS OR A MICROSCOPE HE HAS WITH AN LED LIGHT TO CHECK THEM THROUGH THE PACKAGING" EVER SINCE HIS BLEEDING EVENTS DESCRIBED IN A PREVIOUS CASE AND WILL NOT USE ANY THAT DON'T LOOK SMOOTH TO HIM. HE HAS BEEN SETTING THESE ASIDE AND NOT USING THEM. HE SAID 2 LOOK WORSE THAN THE OTHERS HE HAS COLLECTED AS THEY HAVE "LITTLE PLASTIC PIECES" STICKING OUT FROM EYELETS - HE LABELED THOSE WITH A "W" ON THE PACKAGING FOR WORSE. NO HARM WAS REPORTED FOR THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296697 ↗
• MalfunctionMay 13, 2024Sharp Edges; Sharp Edges

  END USER REPORTS "ROUGH, UNPOLISHED EYELETS" FOUND ON THE HM12 CATHETERS. HE SAID THE "EYELETS STILL DON'T LOOK AS POLISHED WHEN COMPARING TO OTHERS THAT ARE SMOOTH. HE SAID HE HAS BEEN USING A VERY STRONG MAGNIFICATION LENS OR A MICROSCOPE HE HAS WITH AN LED LIGHT TO CHECK THEM THROUGH THE PACKAGING" EVER SINCE HIS BLEEDING EVENTS DESCRIBED IN A PREVIOUS CASE AND WILL NOT USE ANY THAT DON'T LOOK SMOOTH TO HIM. HE HAS BEEN SETTING THESE ASIDE AND NOT USING THEM. HE SAID 2 LOOK WORSE THAN THE OTHERS HE HAS COLLECTED AS THEY HAVE "LITTLE PLASTIC PIECES" STICKING OUT FROM EYELETS - HE LABELED THOSE WITH A "W" ON THE PACKAGING FOR WORSE. NO HARM WAS REPORTED FOR THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296696 ↗
• MalfunctionMay 13, 2024Sharp Edges; Sharp Edges

  END USER REPORTS "ROUGH, UNPOLISHED EYELETS" FOUND ON THE HM12 CATHETERS. HE SAID THE "EYELETS STILL DON'T LOOK AS POLISHED WHEN COMPARING TO OTHERS THAT ARE SMOOTH. HE SAID HE HAS BEEN USING A VERY STRONG MAGNIFICATION LENS OR A MICROSCOPE HE HAS WITH AN LED LIGHT TO CHECK THEM THROUGH THE PACKAGING" EVER SINCE HIS BLEEDING EVENTS DESCRIBED IN A PREVIOUS CASE AND WILL NOT USE ANY THAT DON'T LOOK SMOOTH TO HIM. HE HAS BEEN SETTING THESE ASIDE AND NOT USING THEM. HE SAID 2 LOOK WORSE THAN THE OTHERS HE HAS COLLECTED AS THEY HAVE "LITTLE PLASTIC PIECES" STICKING OUT FROM EYELETS - HE LABELED THOSE WITH A "W" ON THE PACKAGING FOR WORSE. NO HARM WAS REPORTED FOR THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296695 ↗
• MalfunctionMay 13, 2024Sharp Edges; Sharp Edges

  END USER REPORTS "ROUGH, UNPOLISHED EYELETS" FOUND ON THE HM12 CATHETERS. HE SAID THE "EYELETS STILL DON'T LOOK AS POLISHED WHEN COMPARING TO OTHERS THAT ARE SMOOTH. HE SAID HE HAS BEEN USING A VERY STRONG MAGNIFICATION LENS OR A MICROSCOPE HE HAS WITH AN LED LIGHT TO CHECK THEM THROUGH THE PACKAGING" EVER SINCE HIS BLEEDING EVENTS DESCRIBED IN A PREVIOUS CASE AND WILL NOT USE ANY THAT DON'T LOOK SMOOTH TO HIM. HE HAS BEEN SETTING THESE ASIDE AND NOT USING THEM. HE SAID 2 LOOK WORSE THAN THE OTHERS HE HAS COLLECTED AS THEY HAVE "LITTLE PLASTIC PIECES" STICKING OUT FROM EYELETS - HE LABELED THOSE WITH A "W" ON THE PACKAGING FOR WORSE. NO HARM WAS REPORTED FOR THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296694 ↗
• MalfunctionMay 13, 2024Sharp Edges; Sharp Edges

  END USER REPORTS "ROUGH, UNPOLISHED EYELETS" FOUND ON THE HM12 CATHETERS. HE SAID THE "EYELETS STILL DON'T LOOK AS POLISHED WHEN COMPARING TO OTHERS THAT ARE SMOOTH. HE SAID HE HAS BEEN USING A VERY STRONG MAGNIFICATION LENS OR A MICROSCOPE HE HAS WITH AN LED LIGHT TO CHECK THEM THROUGH THE PACKAGING" EVER SINCE HIS BLEEDING EVENTS DESCRIBED IN A PREVIOUS CASE AND WILL NOT USE ANY THAT DON'T LOOK SMOOTH TO HIM. HE HAS BEEN SETTING THESE ASIDE AND NOT USING THEM. HE SAID 2 LOOK WORSE THAN THE OTHERS HE HAS COLLECTED AS THEY HAVE "LITTLE PLASTIC PIECES" STICKING OUT FROM EYELETS - HE LABELED THOSE WITH A "W" ON THE PACKAGING FOR WORSE. NO HARM WAS REPORTED FOR THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296692 ↗
• MalfunctionApr 22, 2024Sharp Edges; Sharp Edges

  CONSUMER REPORTS "HE HAS USED THIS PRODUCT FOR ABOUT 1.5 YRS AND IT WORKED WELL FOR HIM. HE SAID HE HAS HAD BLEEDING IN THE PAST BEFORE SWITCHING TO CURE WITH OTHER BRAND CATHETERS DUE TO UNPOLISHED EYELETS BUT SAID HE HAS NOT HAD THIS ISSUE WITH OUR CURE HM12 UNTIL NOW WITH THIS NEW BOX HE JUST OPENED. HE HAS URINARY RETENTION DUE TO A "VERY ENLARGED PROSTATE", SO LARGE HE SAID HE IS NOT A CANDIDATE FOR LESS INVASIVE PROCEDURES AND WOULD NEED AN INVASIVE SURGERY WHICH HE DOES NOT WANT TO DO AND HAS CHOSEN TO CONTINUE CATHING 1 X PER DAY AND VOIDS REGULARLY THE REST OF THE DAY. HE SAID HE WAS ALREADY TOLD BY HIS MD HE WAS "GOING TO GET SOME BLOOD" EVERY NOW AND THEN WITH CATHING. HE SAID HE DOES NOT TAKE ANY MEDICINES TO SHRINK HIS PROSTATE AS HE IS CONCERNED DRUGS' SIDE EFFECTS. HE SAID HE HAS IDENTIFIED QTY 5 CATHETERS SO FAR FROM THIS BOX (AND HE HASN'T GONE THROUGH THEM ALL OR THE OTHER 2 NEW BOXES HE HAS OF THIS PRODUCT) THAT HAVE ROUGH EYELETS. TWO HE USED AND 3 HE HAS NOT USED. HE SAID HE REMEMBERS THEM ALWAYS HAVING VERY POLISHED ROUNDED EYELETS AND NEVER CAUSED HIM AN ISSUE PRIOR TO THIS BOX BUT PRIOR TO THIS HE NEVER TOOK A MAGNIFYING LENS TO THEM EITHER IN THE PAST. HE S

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19152312 ↗
• MalfunctionApr 22, 2024Sharp Edges; Sharp Edges

  CONSUMER REPORTS "HE HAS USED THIS PRODUCT FOR ABOUT 1.5 YRS AND IT WORKED WELL FOR HIM. HE SAID HE HAS HAD BLEEDING IN THE PAST BEFORE SWITCHING TO CURE WITH OTHER BRAND CATHETERS DUE TO UNPOLISHED EYELETS BUT SAID HE HAS NOT HAD THIS ISSUE WITH OUR CURE HM12 UNTIL NOW WITH THIS NEW BOX HE JUST OPENED. HE HAS URINARY RETENTION DUE TO A "VERY ENLARGED PROSTATE", SO LARGE HE SAID HE IS NOT A CANDIDATE FOR LESS INVASIVE PROCEDURES AND WOULD NEED AN INVASIVE SURGERY WHICH HE DOES NOT WANT TO DO AND HAS CHOSEN TO CONTINUE CATHING 1 X PER DAY AND VOIDS REGULARLY THE REST OF THE DAY. HE SAID HE WAS ALREADY TOLD BY HIS MD HE WAS "GOING TO GET SOME BLOOD" EVERY NOW AND THEN WITH CATHING. HE SAID HE DOES NOT TAKE ANY MEDICINES TO SHRINK HIS PROSTATE AS HE IS CONCERNED DRUGS' SIDE EFFECTS. HE SAID HE HAS IDENTIFIED QTY 5 CATHETERS SO FAR FROM THIS BOX (AND HE HASN'T GONE THROUGH THEM ALL OR THE OTHER 2 NEW BOXES HE HAS OF THIS PRODUCT) THAT HAVE ROUGH EYELETS. TWO HE USED AND 3 HE HAS NOT USED. HE SAID HE REMEMBERS THEM ALWAYS HAVING VERY POLISHED ROUNDED EYELETS AND NEVER CAUSED HIM AN ISSUE PRIOR TO THIS BOX BUT PRIOR TO THIS HE NEVER TOOK A MAGNIFYING LENS TO THEM EITHER IN THE PAST. HE S

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19152310 ↗
• MalfunctionApr 22, 2024Sharp Edges; Sharp Edges

  CONSUMER REPORTS "HE HAS USED THIS PRODUCT FOR ABOUT 1.5 YRS AND IT WORKED WELL FOR HIM. HE SAID HE HAS HAD BLEEDING IN THE PAST BEFORE SWITCHING TO CURE WITH OTHER BRAND CATHETERS DUE TO UNPOLISHED EYELETS BUT SAID HE HAS NOT HAD THIS ISSUE WITH OUR CURE HM12 UNTIL NOW WITH THIS NEW BOX HE JUST OPENED. HE HAS URINARY RETENTION DUE TO A "VERY ENLARGED PROSTATE", SO LARGE HE SAID HE IS NOT A CANDIDATE FOR LESS INVASIVE PROCEDURES AND WOULD NEED AN INVASIVE SURGERY WHICH HE DOES NOT WANT TO DO AND HAS CHOSEN TO CONTINUE CATHING 1 X PER DAY AND VOIDS REGULARLY THE REST OF THE DAY. HE SAID HE WAS ALREADY TOLD BY HIS MD HE WAS "GOING TO GET SOME BLOOD" EVERY NOW AND THEN WITH CATHING. HE SAID HE DOES NOT TAKE ANY MEDICINES TO SHRINK HIS PROSTATE AS HE IS CONCERNED DRUGS' SIDE EFFECTS. HE SAID HE HAS IDENTIFIED QTY 5 CATHETERS SO FAR FROM THIS BOX (AND HE HASN'T GONE THROUGH THEM ALL OR THE OTHER 2 NEW BOXES HE HAS OF THIS PRODUCT) THAT HAVE ROUGH EYELETS. TWO HE USED AND 3 HE HAS NOT USED. HE SAID HE REMEMBERS THEM ALWAYS HAVING VERY POLISHED ROUNDED EYELETS AND NEVER CAUSED HIM AN ISSUE PRIOR TO THIS BOX BUT PRIOR TO THIS HE NEVER TOOK A MAGNIFYING LENS TO THEM EITHER IN THE PAST. HE S

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19152309 ↗
• MalfunctionApr 22, 2024Sharp Edges; Sharp Edges

  CONSUMER REPORTS "HE HAS USED THIS PRODUCT FOR ABOUT 1.5 YRS AND IT WORKED WELL FOR HIM. HE SAID HE HAS HAD BLEEDING IN THE PAST BEFORE SWITCHING TO CURE WITH OTHER BRAND CATHETERS DUE TO UNPOLISHED EYELETS BUT SAID HE HAS NOT HAD THIS ISSUE WITH OUR CURE HM12 UNTIL NOW WITH THIS NEW BOX HE JUST OPENED. HE HAS URINARY RETENTION DUE TO A "VERY ENLARGED PROSTATE", SO LARGE HE SAID HE IS NOT A CANDIDATE FOR LESS INVASIVE PROCEDURES AND WOULD NEED AN INVASIVE SURGERY WHICH HE DOES NOT WANT TO DO AND HAS CHOSEN TO CONTINUE CATHING 1 X PER DAY AND VOIDS REGULARLY THE REST OF THE DAY. HE SAID HE WAS ALREADY TOLD BY HIS MD HE WAS "GOING TO GET SOME BLOOD" EVERY NOW AND THEN WITH CATHING. HE SAID HE DOES NOT TAKE ANY MEDICINES TO SHRINK HIS PROSTATE AS HE IS CONCERNED DRUGS' SIDE EFFECTS. HE SAID HE HAS IDENTIFIED QTY 5 CATHETERS SO FAR FROM THIS BOX (AND HE HASN'T GONE THROUGH THEM ALL OR THE OTHER 2 NEW BOXES HE HAS OF THIS PRODUCT) THAT HAVE ROUGH EYELETS. TWO HE USED AND 3 HE HAS NOT USED. HE SAID HE REMEMBERS THEM ALWAYS HAVING VERY POLISHED ROUNDED EYELETS AND NEVER CAUSED HIM AN ISSUE PRIOR TO THIS BOX BUT PRIOR TO THIS HE NEVER TOOK A MAGNIFYING LENS TO THEM EITHER IN THE PAST. HE S

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19152307 ↗
• MalfunctionApr 22, 2024Sharp Edges; Sharp Edges

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19152304 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTS "UNKNOWN NUMBER OF HM12 CATHETERS, UNKNOWN NUMBER OF MARKET UNITS WITH UNKNOWN LOT NUMBERS OF THE SAME CATHETER OVER THE LAST YEAR OR SO. LOT/S UNKNOWN. COMPLAINT IS CATHETERS STICK TO PACKAGING AFTER ACTIVATION OF HYDROPHILIC COATING. CONSUMER SAID HE HAS BEEN USING THESE CATHETERS FOR 3-4 YEARS WAS HAPPY WITH THEM BUT NOTED THE LAST YEAR OR SO HE WILL GET INCONSISTENT BOXES WHERE CATHETERS WILL STICK TO PACKAGING NEAR THE TIP END TO THE PACKAGING AFTER ACTIVATION OF HYDROPHILIC COATING BY BUSTING WATER SACHET. HE SAID SOMETIMES HE WILL GET A BOX WHERE 3/4 WILL BE ALRIGHT AND THEN 1/4 WILL HAVE THE DEFECT OF STICKING TO PACKING. HE SAID HE WILL THEN GET A SHIPMENT WHERE ALL THE CATHETERS ARE OK. HE SAID IT IS VERY INCONSISTENT AND STATES WE HAVE A POOR QUALITY CONTROL. WHAT MADE HIM CALL TODAY TO FINALLY REPORT THIS IS HE JUST RECENTLY FINISHED A BOX WHERE THE MAJORITY WHERE AFFECTED. HE THREW OUT THE BOX ALREADY. HE PREPARES THEM ALL THE SAME BY POPPING WATER PACKET AND MAKING SURE CATHETER IS SATURATED PRIOR TO IMMEDIATE USE. ON THE DEFECTED CATHETERS HE GOES TO REMOVE THE PACKAGING AND THE PACKAGING WILL CURL WITH IT AND HE HAS TO YANK REALLY HARD TO REMOVE THE

  Patient problems: Urinary Tract Infection

  MAUDE report 15311938 ↗