Wideband™ Self-Adhering Male External Catheter 36102Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741070983), received between Jun 22, 2017 and Sep 17, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 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) MEDICAL 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.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 23075274 ↗
• MalfunctionSep 8, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER HAD STRONG ADHESIVE AT TIMES AND PATIENT EXPERIENCED SKIN IRRITATION. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12438790 ↗
• InjuryNov 13, 2020Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A URINARY TRACT INFECTION FOLLOWING USE OF THE MALE EXTERNAL CATHETER. THE PATIENT BELIEVES THE INFECTION RESULTED FROM NOT CHANGING THE CATHETERS REGULARLY OR KEEPING THE AREA CLEAN. THE CATHETERS ARE REPORTEDLY IN USE FOR ABOUT 5 DAYS BEFORE THEY ARE REPLACED. THE INFECTION WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Urinary Tract Infection

  MAUDE report 10837163 ↗
• MalfunctionAug 8, 2018Component Missing; Device Markings/Labelling Problem; Component Missing

  IT WAS REPORTED THAT THE CATHETER DID NOT COME WITH INSTRUCTIONS FOR USE.

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

  MAUDE report 7763090 ↗
• MalfunctionDec 26, 2017Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT THE ADHESIVE OF THE MALE EXTERNAL CATHETER WAS STRONGER THAN USUAL. THE PATIENT REPORTEDLY EXPERIENCED DIFFICULTY REMOVING THE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7146314 ↗
• MalfunctionJun 22, 2017Material Integrity Problem

  IT WAS REPORTED THAT THE DRAINAGE HOLE OF THE DEVICE HAD NOT BEEN PUNCHED.

  Patient problems: No Information

  MAUDE report 6659920 ↗