Wideband™ Self-Adhering Male External Catheter 36304Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741071089), received between Aug 1, 2017 and Oct 11, 2023 — classified as 5 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER GAVE THE PATIENT BLISTERS. PATIENT SOUGHT MEDICAL ATTENTION. PER FOLLOW UP ON (B)(6) 2023, PATIENT WAS GIVEN A PRESCRIPTION CREAM FOR THE REACTION.

  Patient problems: Blister

  MAUDE report 17912847 ↗
• InjuryJun 19, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT WAS GETTING A RASH ON HIS PENIS, WENT TO THE DOCTOR AND GAVE MEDICATION AND IT IS CLEARING UP.

  Patient problems: Rash

  MAUDE report 17152438 ↗
• MalfunctionMay 22, 2023Inaccurate Flow Rate; Material Twisted/Bent; Inaccurate Flow Rate; Material Twisted/Bent

  IT WAS REPORTED, THAT THE PATIENT WAS HAVING ISSUES WITH THE URINE FLOWS SLOWLY DOWN TUBING IN MALE EXTERNAL CATHETER. PATIENT SAID, THAT IT COULD BE, DUE TO BENT OR KINK IN TUBING, SEDIMENT OR HOW THE BODY WAS RELEASING URINE SLOWER, BUT NOT SURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16975970 ↗
• MalfunctionOct 27, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THERE WAS TOO MUCH ADHESIVE ON THE MALE EXTERNAL CATHETER AND IT WAS CAUSING A PAIN WHEN REMOVING. NO MEDICAL INTERVENTION WAS REPORTED. PER ADDITIONAL INFORMATION RECEIVED VIA (B)(6) ON 17-OCT-2022, IT WAS REPORTED THAT THERE WAS TOO MUCH ADHESIVE ON THE MALE EXTERNAL CATHETER AND IT CAUSED PAIN WHEN REMOVING.

  Patient problems: Pain

  MAUDE report 15680917 ↗
• MalfunctionOct 27, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT USED 7 MALE EXTERNAL CATHETERS AND IT WOULD NOT STAY ON, AND ALSO INDICATED THAT THEY NEVER HAD THIS ISSUE BEFORE, AND THOUGHT THEY WERE TOO STICKY .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680491 ↗
• MalfunctionSep 6, 2022Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED THAT THE TUBING CONNECTION FROM MALE EXTERNAL CATHETER TO TUBING CONSTANTLY KINK AND BEND TO WHERE CATHETER WAS NOT USABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15361435 ↗
• MalfunctionAug 31, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS CAUSING THE SKIN TO COME OFF AND THE PATIENT TO HAVE A URINARY TRACT INFECTION. NO MEDICAL INTERVENTION WAS REPORTED FOR SKIN CAME OFF AND IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Abrasion

  MAUDE report 15327931 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS CAUSING THE SKIN TO COME OFF AND THE PATIENT TO HAVE A URINARY TRACT INFECTION. NO MEDICAL INTERVENTION WAS REPORTED FOR SKIN CAME OFF AND IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 15321678 ↗
• MalfunctionAug 12, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE NOT WORKING. PATIENT HAD LOST A LOT OF WEIGHT, BUT THE CATHETERS WERE NOT STAYING ON. CUSTOMER SAID THAT THEY SEEMED THINNER THEN THEY HAD BEEN . ORDER ALSO DID NOT COME WITH SIZING GUIDES .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15216449 ↗
• MalfunctionFeb 23, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER ADHESIVE WAS VERY STICKY AND ALMOST PAINFUL TO THE PATIENT. PATIENT WANTED TO KNOW IF THE LIBERATOR REPRESENTATIVE HAD ANY LESS ADHESIVE CATHETERS. PATIENT STATED THAT THEY ATTEMPTED TO USE ONE BUT WOULD KEEP THE OTHER FOUR. PATIENT HAD BEEN USING THE PRODUCTS FOR LESS THAN 90 DAYS. NO MEDICAL INTERVENTION WAS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 07FEB2022, IT WAS STATED THAT THE ADHESIVE WAS TOO STRONG WHICH MADE DIFFICULT TO REMOVE THE CATHETERS WITHOUT TEARING THE SKIN.

  Patient problems: Pain; Skin Tears

  MAUDE report 13588209 ↗
• MalfunctionNov 18, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE HARD FOR THE PATIENT TO PUT ON AND REMOVE DUE TO THE AMOUNT OF ADHESIVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10863962 ↗
• MalfunctionNov 7, 2019Nonstandard Device; Nonstandard Device; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED ITCHING WITH USE OF DEVICE. THE ADHESIVE WAS STRONGER THAN USUAL AND CAUSED THE PATIENT TO LEAVE THE MEC ON FOR TWO DAYS. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Itching Sensation; No Consequences Or Impact To Patient

  MAUDE report 9290440 ↗
• MalfunctionJul 3, 2019Product Quality Problem; Product Quality Problem; Defective Device

  IT WAS REPORTED THAT THE WIDEBAND MALE EXTERNAL CATHETER HAD TOO MUCH ADHESIVE WHICH RENDERED THE ADHESIVE "GOOEY" AND ALLEGEDLY AS A RESULT WAS NOT ABLE TO BE USED.

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

  MAUDE report 8757650 ↗
• MalfunctionJun 6, 2019Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE MECS HAD TOO MUCH ADHESIVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8674327 ↗
• InjuryAug 29, 2018Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A RASH AND EXPERIENCED REDNESS AT THE AREA AFTER USING THE MALE EXTERNAL CATHETER. PATIENT WAS REPORTEDLY PRESCRIBED A CREAM (UNCERTAIN OF THE NAME OF THE CREAM) BY HIS DOCTOR TO TREAT THE RASH.

  Patient problems: Erythema; Rash; Skin Discoloration

  MAUDE report 7827221 ↗
• MalfunctionMay 4, 2018Nonstandard Device; Nonstandard Device; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING THE INVESTIGATION IT WAS FOUND THAT ONE OF THE SAMPLES WAS ABOVE THE SPECIFICATION FOR ADHESIVE STRENGTH.

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

  MAUDE report 7487692 ↗
• InjuryAug 1, 2017Difficult to Remove; Sticking

  IT WAS REPORTED THAT THE SHEATHS WERE TOO STICKY AND DIFFICULT TO REMOVE. THE PATIENT REPORTED ON ONE OCCASION TO HAD REMOVED SKIN OFF THEIR PENIS, RESULTING IN AN OPEN WOUND APPROXIMATELY 15 MM X 8 MM, WHICH RESOLVED AFTER 8 DAYS. HOWEVER, THE PATIENT DID NOT SEEK MEDICAL INTERVENTION FOR THE WOUND, BUT KEPT IT CLEAN. ON ANOTHER OCCASION, THE PATIENT HAD TO CUT THE SHEATH OFF AND A PORTION REMAINED ON THE PENIS, AS IT WAS UNABLE TO BE REMOVED UNTIL A FEW DAYS LATER.

  Patient problems: Tissue Damage

  MAUDE report 6758653 ↗
• MalfunctionAug 1, 2017Difficult to Remove

  IT WAS REPORTED THAT THE SHEATHS WERE TOO STICKY AND DIFFICULT TO REMOVE. THE PATIENT REPORTED ON ONE OCCASION TO HAD REMOVED SKIN OFF THEIR PENIS, RESULTING IN AN OPEN WOUND APPROXIMATELY 15 MM X 8 MM, WHICH RESOLVED AFTER 8 DAYS. THE PATIENT DID NOT SEEK MEDICAL INTERVENTION FOR THE WOUND, BUT KEPT IT CLEAN. ON ANOTHER OCCASION, THE PATIENT HAD TO CUT THE SHEATH OFF AND A PORTION REMAINED ON THE PENIS, AS IT WAS UNABLE TO BE REMOVED UNTIL A FEW DAYS LATER.

  Patient problems: Injury

  MAUDE report 6758646 ↗