Wideband™ Self-Adhering Male External Catheter 36302Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00801741071041), received between May 26, 2017 and Dec 30, 2024 — classified as 8 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (16 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2024Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE 10 MALE EXTERNAL CATHETER29MM, MEDIUM, ROCHESTER, EXTRA ADHESIVE PURCHASED THIS ITEM AND WAS EXTERNAL CONDOM CATHETER FOR URINE DRAINAGE. AFTER THE CATHETER WAS INSERTED INTO THE PENIS, IT TOOK ALMOST 4 HOURS TO REMOVE THE PRODUCT. IT WAS VERY STICKY. NO WARNING OR INSTRUCTION TO REMOVE WERE GIVEN ON THE WEBSITE WHICH ADVERTISED THE PRODUCT. IT CAUSED INJURY TO THE PENIS, INCLUDING BLEEDING WHILE TRYING TO REMOVE IT. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 12DEC2024, STATED THAT AFTER INSERTING THE CATHETER, IT REMAINED IN PLACE FOR A DURATION OF 12 HOURS. WHEN THEY ATTEMPTED TO REMOVE IT, THEY ENCOUNTERED SIGNIFICANT DIFFICULTY. THE CATHETER ADHERED STRONGLY TO THE SKIN AND FOUND THAT THEY COULD NOT DETACH IT QUICKLY OR EASILY. IN FACT, THE PROCESS OF REMOVAL TOOK NEARLY TWO HOURS, DURING WHICH THEY HAD TO BE EXTREMELY CAUTIOUS TO AVOID CAUSING FURTHER DISCOMFORT. AS THEY SLOWLY WORKED TO PEEL IT AWAY, THEY NOTICED THAT THE ADHESIVE WAS EXCESSIVELY STICKY, LEADING TO IRRITATION OF THE SKIN ON THE PENIS. UNFORTUNATELY, THIS RESULTED IN INJURY AND SUBSEQUENT BLEEDING FROM THE SITE OF INJURY. IT TOOK ALMOST A WEEK FOR THE INJURY SITE TO HEAL AND TOPIC

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation

  MAUDE report 21036924 ↗
• MalfunctionApr 24, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WOULD HOLD FOR UP TO ONE HOUR AND LATER WOULD FALL OFF. ALSO STATED THAT THE CATHETERS WERE STICKING. THE CUSTOMER REPLACED THE CATHETERS WITH A DIFFERENT LOT. PER NOTIFICATION RECEIVED FROM INVESTIGATOR ON (B)(6) 2023, IT WAS STATED THAT THE STRONG ADHESIVE THAT WAS FOUND DURING THE SAMPLE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16796739 ↗
• MalfunctionJan 23, 2023Nonstandard Device; Insufficient Device Problem Information; Nonstandard Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THE ADHESIVE STRENGTH OF THE CONDOM URINALS ADHERE ONLY BRIEFLY AND SLIP OFF WITH EVERY MOVEMENT. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 30NOV2022, STATED THAT THE PATIENT COMPLAINS ABOUT THE ADHESION AND THE LENGTH OF THE WEARING TIME TO INSUFFICIENT ADHESION. ALSO STATED THAT THERE WAS NO INFORMATION ON THE CONNECTION WITH A URINE BAG. BASED ON SAMPLE EVALUATION RECEIVED ON 12DEC2022, STATED THAT STRONG ADHESION WAS FOUND IN MALE EXTERNAL CATHETER. BASED ON SAMPLE EVALUATION RECEIVED ON 04JAN2023, STATED THAT STRONG ADHESION WAS FOUND IN MALE EXTERNAL CATHETER FOR THE ADDITIONAL SAMPLES RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223562 ↗
• MalfunctionDec 30, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS DID NOT HAVE ENOUGH ADHESIVE AND FELL OFF IMMEDIATELY AFTER INSERTION. PER SAMPLE EVALUATION RESULTS RECEIVED ON (B)(6) 2022, IT WAS REPORTED THAT THE STRONG ADHESIVE WAS FOUND DURING SAMPLE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16078135 ↗
• MalfunctionDec 28, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THE ADHESIVE STRENGTH OF THE CONDOM URINALS ADHERE ONLY BRIEFLY AND SLIP OFF WITH EVERY MOVEMENT. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 30NOV2022, STATED THAT THE PATIENT COMPLAINS ABOUT THE ADHESION AND THE LENGTH OF THE WEARING TIME TO INSUFFICIENT ADHESION. ALSO STATED THAT THERE IS NO INFORMATION ON THE CONNECTION WITH A URINE BAG. BASED ON SAMPLE EVALUATION RECEIVED ON 12DEC2022, STATED THAT STRONG ADHESION WAS FOUND IN MALE EXTERNAL CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061092 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS CONSTRICT THE PATIENT PENIS. PATIENT BELIEVED THEY WERE CAUSING URINARY TRACT INFECTIONS. PATIENT DID NOT SPECIFY THE QUANTITY AFFECTED. PATIENT HAS USED THIS PRODUCT BEFORE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 15427885 ↗
• InjurySep 1, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT HAD A URINARY TRACT INFECTION. IT WAS UNKNOWN IF THE MALE EXTERNAL CATHETER CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN. PER FOLLOW UP VIA PHONE ON 24AUG2022, IT WAS REPORTED THAT PATIENT HAD A RARE DISEASE AND WAS ON A HIGH DOSE OF IRON. CUSTOMER STATED THAT PATIENT WAS PRESCRIBED ANTIBIOTICS AFTER GOING TO THE DOCTOR FOR BLOOD IN URINE. STATED THAT THE URINE CULTURE SHOWED NO URINARY TRACT INFECTION AND CUSTOMER DID NOT THINK THE MALE EXTERNAL CATHETER HAD ANYTHING TO DO WITH THE BLOOD IN PATIENT'S URINE.

  Patient problems: Hematuria

  MAUDE report 15334701 ↗
• MalfunctionJun 11, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE TUBING AT THE END OF THE MALE EXTERNAL CATHETER WOULD CLOSE UP AND GOT STUCK CAUSED URINE TO BACK UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14670113 ↗
• MalfunctionJun 1, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE PAINFUL TO REMOVE EVEN WITH SOAPY WATER AND VASELINE (PCN# 35302 AND PCN# 36302). IT WAS STATED THAT THE PATIENT EXPERIENCED SORE AND PAIN. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 14565922 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO URINARY TRACT INFECTIONS BACK-TO-BACK. THE FIRST URINARY TRACT INFECTION OCCURRED IN JANUARY. THE INFECTION LATER REAPPEARED, HOWEVER THE PATIENT IS NOW USING A DIFFERENT ANTIBIOTIC. THE PATIENT NOTED THAT IT MAY BE THE MALE EXTERNAL CATHETER. IT WAS ALSO NOT THAT CATHETER CRINKLED AND THE ADHESIVE DID NOT HOLD UP WELL AND A POOL OF URINE FORMED WHICH MAY HAVE CAUSED THE URINARY TRACT INFECTION. IT IS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTIONS AT THIS TIME AND MEDICAL INTERVENTION IS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 13903892 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCING TWO URINARY TRACT INFECTIONS BACK TO BACK. FIRST THE URINARY TRACT INFECTIONS WAS OCCURRED AT THE JANUARY. THE INFECTION CAME BACK AND NOW ON DIFFERENT ANTIBIOTIC. PATIENT SAID IT MIGHT BE THE MALE EXTERNAL CATHETER. PATIENT SAID IT CRINKLED UP AND THE ADHESIVE DID NOT HOLD UP VERY WELL. IT FORMED A URINE POOL AND MIGHT BE WHAT CAUSED THE URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 13893570 ↗
• MalfunctionDec 31, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE STICKING TOO MUCH, MAKING IT DIFFICULT TO REMOVE THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13125539 ↗
• MalfunctionOct 29, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER HAD NO DIRECTIONS. THE CUSTOMER STATED THAT THE ADHESIVE STUCK TOGETHER, AND THEY WERE UNABLE TO ROLL DOWN. IT WAS ALSO STATED THAT THE CATHETERS WERE TOO SMALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12724345 ↗
• MalfunctionJul 22, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER TORE THE FIRST LAYER OF PATIENT SKIN OFF. THE PATIENT STATED THEY WENT TO THE HOSPITAL AS THE CATHETER WAS TOO STICKY. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Skin Tears

  MAUDE report 12211584 ↗
• InjuryJul 12, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT WAS GETTING A LOT OF URINARY TRACT INFECTIONS WHILE USING MALE EXTERNAL CATHETER. THE UROLOGIST TOLD PATIENT NOT TO USE THE MALE EXTERNAL CATHETER AT NIGHT AND THAT WAS WHAT THE PATIENT WANTED THE CATHETER FOR. SO THE PATIENT WAS NOT USING THE CATHETER ANY LONGER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE, STATED THAT PATIENT HAD TROUBLE ADVANCED CATHETER FROM THE BAG AND THEREFORE IT WAS HARD TO INSERT. ALSO THE CATHETER WAS TOO LARGE AND BULKY FOR THE SUITCASE AT THE TIME OF TRAVELLING OUTSIDE OF THE COUNTRY. THE PATIENT CHANGED TO A DIFFERENT CATHETER.

  Patient problems: Urinary Tract Infection

  MAUDE report 12155933 ↗
• MalfunctionApr 2, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE SAMPLES OF THE MALE EXTERNAL CATHETERS WITH ADHESIVE WERE DIFFICULT TO REMOVE. PATIENT STATED THAT USING A SOAPY WATER DID NOT REALLY HELP WITH REMOVING THESE EXTERNALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11607328 ↗
• MalfunctionMar 23, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD ISSUES WITH THE MALE EXTERNAL CATHETER WHICH HAD TOO MUCH ADHESIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11553421 ↗
• MalfunctionOct 28, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE CATHETER WAS TOO STICKY FROM THE INSIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10751781 ↗
• MalfunctionAug 7, 2020Nonstandard Device; Use of Device Problem; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER DIFFICULT TO REMOVE, ESPECIALLY IN THE FRONT AREA WHICH RESULTED IN BRUISES AND SKIN TEAR. ALSO REPORTED THAT THE PATIENT USED THE CATHETER DURING DIVING AND THE INDICATED INCIDENT HAPPENED AFTER THE LAST DIVES. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Bruise/Contusion; Skin Tears

  MAUDE report 10380008 ↗
• MalfunctionJul 17, 2020Partial Blockage; Obstruction of Flow; Partial Blockage

  IT WAS REPORTED THAT THE CATHETER SEEMS TO CLOG.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10290285 ↗
• MalfunctionMay 20, 2020Nonstandard Device; Nonstandard Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BOUGHT BARD ¿SELF ADHERING MALE EXTERNAL CATHETERS¿ (URINAL CONDOMS) FROM A DIVING SHOP, AS THEY ARE OFTEN USED IN DIVING. REF (B)(4), 29MM. THE USE OF THE FIRST DEVICE WAS ALMOST WITHOUT PROBLEMS. BUT THE SECOND ONE SHOWED SUCH ENORMOUS ADHESIVE STRENGTH WHEN IT WAS WORN FOR ABOUT 6 HOURS THAT IT COULD ONLY BE REMOVED WITH SEVERE PAIN AND SKIN DAMAGE IN THE FRONT AREA [OF PENIS]. NO PHOTOGRAPHIC OR MEDICAL EVIDENCE EXISTS FOR THIS REASON. HOWEVER, WITH ANOTHER DEVICE, THE PATIENT SIMULATED A SIMULATED APPLICATION (5 MINUTES OF USE, ROOM TEMPERATURE) ON A BANANA, WHICH CONSIDERED TO BE SUITABLE FOR SIMULATING SENSITIVE SKIN. THE PATIENT ATTACHED PHOTOS OF THE EXPERIMENT AS AN ATTACHMENT. THE PATIENT CAN CLEARLY SEE, THE ADHESIVE LAYER CLEARLY DAMAGED THE SURFACE OF THE FRUIT AND TORE OUT CLEARLY VISIBLE PIECES.

  Patient problems: Pain; Patient Problem/Medical Problem; Skin Tears

  MAUDE report 10074237 ↗
• InjuryApr 20, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLEEDING AND A UTI WHILE USING THE EXTERNALS AND WAS TOLD BY HIS DOCTOR TO DISCONTINUE USE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem; Urinary Tract Infection

  MAUDE report 9977490 ↗
• MalfunctionJan 3, 2020Nonstandard Device; Nonstandard Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE GLUE MADE THE CATHETERS STICK TOGETHER. THE PATIENT WAS NOT ABLE TO USE THE CATHETERS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9545134 ↗
• InjuryAug 14, 2019Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT URINE WOULD NOT DRAIN OUT OF THE MALE EXTERNAL CATHETER WHICH ALLEGEDLY MADE THE PATIENT'S SKIN SORE AND CAUSED AN INFECTION. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CONTACT VIA PHONE ON (B)(6) 2019, THE INFECTION WAS TREATED WITH PRESCRIBED ANTIBIOTICS FROM THE PATIENT'S DOCTOR.

  Patient problems: Skin Irritation; Unspecified Infection

  MAUDE report 8892373 ↗
• MalfunctionJan 2, 2019Nonstandard Device; Difficult to Remove; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTIES REMOVING THE WIDEBAND CONDOM CATHETER, ALLEGEDLY DUE TO STRONG ADHESIVE. HE WAS ABLE TO REMOVE THE CATHETER USING ZWITSAL, BABY OIL, BANDAGE, SCISSORS, AND TWEEZERS. THE PATIENT ALLEGEDLY EXPERIENCED PAIN, SKIN IRRITATION, AND TWO BRUISES ON THE FORESKIN UPON REMOVAL OF THE CATHETER. THE PATIENT REPORTED HE PROPERLY WASHED HIS PENIS ACCORDING TO THE INSTRUCTIONS, REMOVED HAIRS, AND APPLIED THE CONDOM, WITH THE CHARACTERISTICS OF THE WIDEBAND.

  Patient problems: Bruise/Contusion; Pain; Skin Irritation

  MAUDE report 8210089 ↗