Wideband™ Self-Adhering Male External Catheter 36101Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741070976), received between Nov 6, 2017 and Nov 10, 2025 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE WOUND CARE NURSE AT THE (B)(6) CENTER. THEY CURRENTLY RECEIVED BD CONDOM CATHETERS FROM THEIR DISTRIBUTORS FOR USE ON THEIR VETERANS BUT DO NOT SEEM TO HAVE SIZERS FOR PROPER MEASURING TO APPLY THE CORRECT SIZE PER PATIENT. THEY HAVE BEEN EXPERIENCING AN INCREASE IN THE NUMBER OF MEDICAL DEVICE RELATED PRESSURE INJURIES LATELY WITH THE USE OF CONDOM CATHETERS AND BELIEVE IT WAS IN RELATION TO NOT SECURING TO CORRECT SIZE. NO MEDICAL INTERVENTION WAS REPORTED. CUSTOMER EMAIL RESPONSE RECEIVED ON 04NOV2025. IT WAS REPORTED THAT, "THE LOT NUMBERS FOR THE CONDOM CATHETERS THAT WERE USED MOST OFTEN ARE AS FOLLOWS: 29MM REF 36102 LOT NUMBER: JUKQ1552, 25MM REF 36101 LOT NUMBER: JUKV1982. THERE WERE NO DEFECTS IN THE PRODUCTS. CUSTOMER CAN ATTRIBUTE THE MINOR SKIN INJURIES TO USE OF THE INCORRECT SIZE DEVICE FOR SELECTED PATIENTS. IT WAS BROUGHT TO CUSTOMER'S ATTENTION THAT THE NURSING STAFF WERE NOT PROVIDED WITH ACCURATE SIZING GUIDES TO ASSIST THEIR CHOICES. THESE INJURIES WERE CHARACTERIZED AS MEDICAL DEVICE RELATED PRESSURE INJURIES FOR PATIENTS, NOW HEALED AND LONG DISCHARGED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 23518896 ↗
• MalfunctionAug 4, 2022Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER SLIPS OFF BECAUSE IT WAS NOT ADHESIVE ENOUGH. STATED THAT THE CATHETER APPEARED THINNER. ALSO STATED THAT THE CUSTOMER RECEIVED THE ORDER FROM BYRAM 30 DAYS AGO, BUT THE CATHETER HAD AN EXPIRATION DATE OF 12/20/2016. PER FOLLOW UP VIA PHONE ON (B)(6) 2022, IT WAS REPORTED THAT THE SITUATION HAS NOT BEEN RESOLVED. PATIENT CONFINED TO A WHEELCHAIR SINCE PARTIALLY PARALYZED. PATIENT COULD NOT MOVE AROUND AT NIGHT WHEN IN BED AND WOKE UP ONE MORNING COMPLETELY DRENCHED IN URINE. THIS HAS OCCURRED WHILE THEY USE WHEELCHAIR TOO. STATED THAT THE CATHETERS APPEAR DEFECTIVE RIGHT OUT OF THE BOX. CUSTOMER PROVIDED TWO CATALOG NUMBERS WERE PCN-36101 WITH LOT# JUGN9178- AND PCN-36301-PROVIDED THROUGH BYRAM HEALTHCARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15166713 ↗
• MalfunctionMay 11, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE CUSTOMER HAVE BEEN EXPERIENCING AN ADHESIVENESS ISSUE WITH THE MALE EXTERNAL CATHETER. THIS ISSUE HAS OCCURRED MULTIPLE TIMES AND HAS CAUSED BLEEDING. ADDITIONALLY, THE CUSTOMER THOUGHT THE LAST REPLACEMENTS THEY RECEIVED MAY HAVE BEEN EXPIRED AND CONTRIBUTED TO THIS ISSUE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 15APR2022, CUSTOMER RETURNED ADDITIONAL MALE EXTERNAL CATHETER FROM DIFFERENT LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14359091 ↗
• MalfunctionMar 8, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCING AN ADHESIVENESS ISSUE WITH THE MALE EXTERNAL CATHETER. THIS ISSUE HAS OCCURRED MULTIPLE TIMES AND CAUSED BLEEDING. ADDITIONALLY, THE CUSTOMER THOUGHT THE LAST REPLACEMENTS THEY RECEIVED MAY HAVE BEEN EXPIRED AND CONTRIBUTED TO THIS ISSUE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13694178 ↗
• MalfunctionNov 3, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE CUSTOMER HAD ISSUES WITH THE MALE EXTERNAL CONDOM CATHETER AND HAD DIFFICULTY WHILE REMOVING THE CATHETER. ALSO STATED THAT THE RESIDUE STAYED ON THE PATIENT¿S ANATOMY AND WAS HARD TO REMOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745356 ↗
• MalfunctionJun 17, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT MALE EXTERNAL CATHETER WAS STICKY AND THE GLUE ON THE CONDOM HAD TURNED WHITE. WHEN CUSTOMER REMOVED THE CATHETER, THE GLUE STAYED STUCK ON THE SKIN AND CAUSED MINOR TEARING. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP CALL ON (B)(6) 2021, INITIAL REPORTER STATED THE CUSTOMER HAD TO GENTLY REMOVE USING ALCOHOL OR OTHER SOLUTION TO ASSIST WITH REMOVAL. THE CUSTOMER HAD NEVER SEEN THE GLUE GET WHITE LIKE IT WAS. NO MEDICAL CARE HAS BEEN REPORTED. PER CUSTOMER VIA PHONE ON (B)(6) 2021, THE CUSTOMER STATED THAT THE WHITE SUBSTANCE WAS BEING LEFT ON THE PENIS, AND IT WAS SOMEWHAT STICKY LIKE THE GLUE WAS LEFT BEHIND. ALSO, THE CUSTOMER FELT LIKE THE CATHETERS WERE OLD BECAUSE THEY HAD SMALL PRINT ON THE PACKAGING, BUT THE BETTER ONES HAVE LARGE PRINT. IT WAS STATED THAT WHEN TRIED TO REMOVE THE WHITE POWER THAT WAS LEFT ON THE PENIS, THE RUBBING CAUSED THE SKIN TO COME OFF AND CAUSED SOME BLEEDING. THE CUSTOMER DID NOT GO TO THE DOCTOR AND REPORTED THAT THE CUSTOMER WAS HEALING SLOWLY. PER INVESTIGATOR NOTIFICATION RECEIVED ON (B)(6) 2021, DURING SAMPLE EVALUATION A WEAK ADHESIVE WAS FOUND ON THE CATHETER. PER CUSTOMER VIA PHONE ON (B)(6) 2021, THE CUSTOMER

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Skin Tears

  MAUDE report 12014285 ↗
• MalfunctionMar 27, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT MALE EXTERNAL CATHETER HAD TOO ADHESIVE WHICH CAUSED THE PATIENT PAIN WHILE REMOVING THE CATHETER . THE CUSTOMER PREFERRED NEXT SIZE 27 MM, BUT STILL PATIENT FEARED IF THE ADHESIVE FOR THAT ONE WAS JUST AS STRONG AS, IT MIGHT END UP INJURING. THE CUSTOMER ASKED IF THEY COULD APPLY ANYTHING PRIOR USING THE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED. PER CUSTOMER VIA EMAIL ON 04JUN2021, IT WAS STATED THAT CUSTOMER WAS USING ADAPT, BY HOLLISTER 7731 AND 7737 MEDICAL ADHESIVE REMOVER AND CUSTOMER BELIEVED THE DIFFERENT PRODUCT NUMBERS WERE ONLY DUE TO THE LARGE AND SMALL SIZE SPRAY BOTTLES. IT WAS ALSO STATED THAT NOW THE PRODUCT WORKED GREAT AND WELL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 11578806 ↗
• MalfunctionJun 19, 2019Product Quality Problem; Product Quality Problem; Material Deformation

  IT WAS REPORTED THAT THE CATHETERS WERE TOO LUBRICIOUS MAKING THEM DIFFICULT TO UNROLL AND UNUSABLE.

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

  MAUDE report 8713920 ↗
• MalfunctionAug 9, 2018Nonstandard Device; Product Quality Problem; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER ADHESIVE WAS TOO STRONG.

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

  MAUDE report 7768234 ↗
• InjuryNov 6, 2017Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED AN UTI AND WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Urinary Tract Infection

  MAUDE report 7002747 ↗