Wideband™ Self-Adhering Male External Catheter 36301Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741071027), received between Sep 4, 2018 and Dec 28, 2022 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2022Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT THE LABELS DID NOT MATCH THE MALE EXTERNAL EXTERNAL CATHETERS. THE CUSTOMER HAD ORDERED TWO PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060326 ↗
• MalfunctionJan 29, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS HAVE BEEN FALLING OFF WITHIN AN HOUR OF PUTTING THEM ON. THE PATIENT WAS EXPERIENCING SOME SKIN BREAKDOWN ON THE SCROTUM. ALSO REPORTED THAT THEY HAD ANOTHER BATCH WHICH THEY REALLY HAD TO PULL AND REMOVE THE MALE EXTERNAL CATHETERS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Skin Inflammation/ Irritation

  MAUDE report 13390064 ↗
• InjuryMar 4, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD URINARY TRACT INFECTION AND WAS ADMINISTERED WITH ANTIBIOTICS BY THE DOCTOR WHICH CLEARED IT UP.

  Patient problems: Urinary Tract Infection

  MAUDE report 11411616 ↗
• InjurySep 13, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT PATIENT WAS TREATED FOR A URINARY TRACT INFECTION 2 WEEKS AGO. IT WAS UNKNOWN IF THE MALE EXTERNAL CATHETER CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND TREATMENT PROVIDED WAS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 10526250 ↗
• InjuryJun 1, 2020Biocompatibility; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT ACQUIRED A URINARY TRACT INFECTION AS A RESULT OF USING MALE EXTERNAL CATHETER. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 10106373 ↗
• MalfunctionMay 13, 2019Nonstandard Device; Therapeutic or Diagnostic Output Failure; Nonstandard Device

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

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

  MAUDE report 8604955 ↗
• MalfunctionJan 29, 2019Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S SKIN RIPPED WHILE REMOVING THE MALE EXTERNAL CATHETERS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Tissue Breakdown

  MAUDE report 8286472 ↗
• InjurySep 4, 2018Inaccurate Flow Rate; Infusion or Flow Problem; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WOULD NOT DRAIN PROPERLY. THE URINE POOLED INSIDE OF THE TIP OF THE CATHETER IN THE AMOUNT OF A TABLESPOON AND. ALLEGEDLY, THIS CAUSED THE PATIENT TO INHERIT A UTI (URINARY TRACT INFECTION) AND WAS PRESCRIBED ANTIBIOTICS.

  Patient problems: Urinary Tract Infection

  MAUDE report 7843668 ↗