Wideband™ Self-Adhering Male External Catheter 36104Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741071003), received between Oct 26, 2017 and May 31, 2021 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (5 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.

• MalfunctionMay 31, 2021No Apparent Adverse Event; Illegible Information; No Apparent Adverse Event; Illegible Information

  IT WAS REPORTED THAT THE PATIENT WAS NOT SURE ABOUT REMOVING THE MALE EXTERNAL CATHETER AS THEY TRY TO ROLL IT DOWN LIKE THE INSTRUCTIONS SAY, BUT IT WOULD NOT COME OFF. REPRESENTATIVE DISCUSSED WITH PATIENT IF NECESSARY, TO APPLY A WARM WET COMPRESS, SUCH AS A WET WASHCLOTH AROUND THE CATHETER TO HELP LOOSEN THE ADHESIVE. ADVISED TO GENTLY TO ROLL THE CATHETER OFF THE PENIS. PATIENT HAD A BOX OF 100 AND HAD USED ABOUT 40-50 AND ALL OF THEM HAD PRESENTED WITH THE SAME ISSUE. ALSO, NOTED THAT THEY WERE EXTREMELY DIFFICULT TO GET OFF THE PLASTIC LID, THE SOMBRERO. PATIENT STATED THAT THEY DID NOT JUST POP OFF LIKE THE INSTRUCTIONS SAY. PER FOLLOW UP VIA PHONE ON 07MAY2021,CUSTOMER STATED THAT THE INSTRUCTIONS NEED TO BE MORE CLEAR BECAUSE IT WAS DIFFICULT TO UNDERSTAND HOW TO REMOVE THE CATHETER FROM THE SOMBRERO. AND ALSO STATED THAT THE CATHETER WAS TOO STICKY SO IT WAS DIFFICULT TO REMOVE FROM THE PATIENT AFTER USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11909324 ↗
• MalfunctionMay 10, 2021Nonstandard Device; Difficult to Remove; Nonstandard Device; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT WAS UNSURE IN REMOVING THE MALE EXTERNAL CATHETER AS THE PATIENT WAS TRYING TO ROLL IT DOWN AS MENTIONED IN THE INSTRUCTIONS BUT IT WOULD NOT COME OFF. THE REPRESENTATIVE DISCUSSED WITH THE PATIENT IF NECESSARY TO APPLY A WARM WET COMPRESS SUCH AS A WET WASHCLOTH AROUND THE CATHETER TO HELP TO LOOSEN THE ADHESIVE. IT WAS ADVISED TO GENTLY ROLL THE CATHETER OFF THE PENIS. THE PATIENT HAS A BOX OF 100 AND USED ABOUT 40 TO 50 AND ALL OF THEM WERE PRESENTED WITH THE SAME ISSUE. ALSO NOTED THAT THEY WERE EXTREMELY DIFFICULT TO GET OFF THE PLASTIC LID OF THE SOMBRERO. THE PATIENT STATED THAT THEY DID NOT JUST POP OFF AS MENTIONED IN THE INSTRUCTIONS. PER FOLLOW UP VIA PHONE ON 07MAY2021, CUSTOMER STATED THAT THE INSTRUCTIONS NEED TO BE MORE CLEAR BECAUSE IT WAS DIFFICULT TO UNDERSTAND HOW TO REMOVE THE CATHETER FROM THE SOMBRERO. AND ALSO STATED THAT THE CATHETER WAS TOO STICKY SO IT WAS DIFFICULT TO REMOVE FROM THE PATIENT AFTER USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11801566 ↗
• InjuryOct 28, 2020Loss of or Failure to Bond; Decrease in Pressure; Loss of or Failure to Bond; Decrease in Pressure

  IT WAS REPORTED THAT THE CATHETERS WERE STAYING ATTACHED FOR LESS THAN 24 HOURS, SUPPOSEDLY CAUSED THE LEAK AND BLADDER INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10747973 ↗
• InjuryNov 9, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED IRRITATION AND SKIN PEELING WITH THE USE OF THE MALE EXTERNAL CATHETER. PATIENT REPORTEDLY HAS A LATEX ALLERGY AND HAS BEEN USING THE CATHETERS FOR ABOUT 6 MONTHS. THE PATIENT REPORTEDLY RECEIVED "A SPECIAL SPRAY" FROM HIS DOCTOR TO TREAT THE REACTION.

  Patient problems: Irritation; Skin Tears

  MAUDE report 8056076 ↗
• MalfunctionSep 25, 2018Nonstandard Device; Material Integrity Problem; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE OF THE CATHETER WAS TOO STRONG.

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

  MAUDE report 7905599 ↗
• MalfunctionJun 12, 2018Nonstandard Device; Sticking; Material Integrity Problem; Nonstandard Device

  IT WAS REPORTED THAT THE CATHETER HAD TOO MUCH ADHESIVE, MAKING IT TOO STICKY. THE PATIENT REPORTEDLY HAD TO SOAK IN WATER IN ORDER TO GET THE ADHESIVE OFF.

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

  MAUDE report 7592051 ↗
• InjuryJun 11, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED A UTI AFTER USING THE MALE EXTERNAL CATHETER. THE UTI WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Urinary Tract Infection

  MAUDE report 7586664 ↗
• MalfunctionJun 4, 2018Nonstandard Device; Difficult to Remove; Device Operates Differently Than Expected; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETERS WERE TOO STRONG, WHICH MADE IT DIFFICULT TO REMOVE FROM THE SKIN. THE PATIENT ALLEGEDLY USED A WARM COMPRESS TO HELP REMOVE THE MALE EXTERNAL CATHETER, HOWEVER IT TOOK A LONG TIME FOR IT TO BE REMOVED.

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

  MAUDE report 7566767 ↗
• MalfunctionMar 23, 2018Nonstandard Device; Nonstandard Device; Output above Specifications

  DURING THE EVALUATION OF THE LOT SAMPLES RECEIVED FOR A SEPARATE COMPLAINT, ONE OF THE SAMPLES WAS FOUND TO BE ABOVE THE SPECIFICATION FOR PEEL STRENGTH. THEREFORE, THIS COMPLAINT WAS ENTERED TO CAPTURE THE MALFUNCTION OF THE SAMPLE.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 7365051 ↗
• MalfunctionOct 26, 2017Difficult to Remove; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE ADHESIVE WAS DIFFICULT TO REMOVE FROM THE SKIN OF THE PATIENT. THE PATIENT ALLEGEDLY ATTEMPTED TO USE SMITH & NEPHEW REMOVE AND UNI-SOLVE ADHESIVE REMOVERS.

  Patient problems: No Information

  MAUDE report 6979719 ↗