Wideband™ Self-Adhering Male External Catheter 36103Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741070990), received between Jun 5, 2017 and Jul 28, 2023 — 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.

• MalfunctionJul 28, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE GLUE SUBSTANCE WAS STUCK TO APPLICATION AREA, CAUSING RAW SKIN AND WAS UNCOMFORTING. NO MEDICAL INTERVENTION WAS REPORTED. AS PER FOLLOW UP VIA PHONE ON (B)(6) 2023, IT WAS REPORTED THAT PATIENT'S PROSTATE WAS REMOVED TWO MONTHS AGO. THE BATCH OF MALE EXTERNAL CATHETERS THEY RECEIVED HAD FAR TOO MUCH ADHESIVE TO THE POINT WHERE THEY HAD TO USE SCISSORS TO GENTLY CUT AWAY ANY RESIDUAL RESIDUE. THEY USED RUBBING ALCOHOL AS WELL, BUT IT DID LITTLE TO RESOLVE THE ISSUE.

  Patient problems: Discomfort; Skin Inflammation/ Irritation

  MAUDE report 17413706 ↗
• InjuryMay 19, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE ADHESIVE ON THE MALE EXTERNAL CATHETERS. THE CUSTOMER HAD TWO BOXES OF CATHETERS (BATCH# JUGT1701 AND BATCH# JUGU9119). ON (B)(6) 2022, THE CUSTOMER STATED THAT THE BOX OF CATHETERS WERE NOT WORKING AND THEY KEPT COMING OFF. THE CUSTOMER STATED THAT THEY HAD TO CHANGE THE CATHETERS FOUR TIMES BECAUSE THEY KEPT COMING OFF. SO THE REPRESENTATIVE RECOMMENDED TO USE THE PRODUCT FROM THE BOTTOM OF THE BOX AS THE TOP PRODUCT MIGHT BE DEFECTIVE ON (B)(6) 2022. ON (B)(6) 2022, THE CUSTOMER STATED THAT THEY PICKED THE CATHETERS FROM THE BOTTOM AS RECOMMENDED BY REPRESENTATIVE. HOWEVER, THE CUSTOMER HAD TO CHANGE 2 CATHETERS AS THEY WERE STILL COMING OFF AND THE PATIENT WAS GETTING WET. ON (B)(6) 2022, THEY CUSTOMER STATED THAT THE PATIENT WAS NOT ABLE TO GET INTO THEIR CHAIR BECAUSE THEY KEPT GETTING WET AND HAD TO STAY IN BED. THE CUSTOMER COULD NOT GO OUT BECAUSE THEY HAD TO MAKE SURE TO KEEP CHANGING THE PATIENT'S CATHETER AND CLEAN THEM SO THAT THEY DO NOT GET INFECTIONS. THEY COULD NOT GO OUT BECAUSE THE CATHETERS KEPT LEAKING. AS PER FOLLOW-UP INFORMATION RECEIVED ON 27JAN2023, STATED THAT BOTH OF THE BOXES OF CONDOMS LEAKED

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 16961147 ↗
• InjuryFeb 13, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE ADHESIVE ON THE MALE EXTERNAL CATHETERS. THE CUSTOMER HAD TWO BOXES OF CATHETERS (BATCH#: JUGT1701 AND BATCH#: JUGU9119). ON 14DEC2022, THE CUSTOMER STATED THAT THE BOX OF CATHETERS WERE NOT WORKING AND THEY KEPT COMING OFF. THE CUSTOMER STATED THAT THEY HAD TO CHANGE THE CATHETERS FOUR TIMES BECAUSE THEY KEPT COMING OFF. SO THE REPRESENTATIVE RECOMMENDED TO USE THE PRODUCT FROM THE BOTTOM OF THE BOX AS THE TOP PRODUCT MIGHT BE DEFECTIVE ON 14DEC2022. ON 15DEC2022, THE CUSTOMER STATED THAT THEY PICKED THE CATHETERS FROM THE BOTTOM AS RECOMMENDED BY REPRESENTATIVE. HOWEVER, THE CUSTOMER HAD TO CHANGE 2 CATHETERS AS THEY WERE STILL COMING OFF AND THE PATIENT WAS GETTING WET. ON 18DEC2022, THE CUSTOMER STATED THAT THE PATIENT WAS NOT ABLE TO GET INTO THEIR CHAIR BECAUSE THEY KEPT GETTING WET AND HAD TO STAY IN BED. THE CUSTOMER COULD NOT GO OUT BECAUSE THEY HAD TO MAKE SURE TO KEEP CHANGING THE PATIENT'S CATHETER AND CLEAN THEM SO THAT THEY DO NOT GET INFECTIONS. THEY COULD NOT GO OUT BECAUSE THE CATHETERS KEPT LEAKING. PER FOLLOW-UP INFORMATION RECEIVED ON 27JAN2023, STATED THAT BOTH OF THE BOXES OF CONDOMS LEAKED. THE PATI

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 16365175 ↗
• InjuryJan 31, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE ADHESIVE ON THE MALE EXTERNAL CATHETERS AND INTERMITTENT CATHETERS. THE CUSTOMER HAD TWO BOXES OF CATHETERS (BATCH# JUGT2701 AND BATCH# JUGU9119). ON (B)(6) 2022, THE CUSTOMER STATED THAT THE BOX OF CATHETERS WERE NOT WORKING, AND THEY KEPT COMING OFF. THE CUSTOMER STATED THAT THEY HAD TO CHANGE THE CATHETERS FOUR TIMES BECAUSE THEY KEPT COMING OFF. SO THE REPRESENTATIVE RECOMMENDED USING THE PRODUCT FROM THE BOTTOM OF THE BOX AS THE TOP PRODUCT MIGHT BE DEFECTIVE ON (B)(6) 2022. ON (B)(6) 2022, THE CUSTOMER STATED THAT THEY PICKED THE CATHETERS FROM THE BOTTOM AS RECOMMENDED BY REPRESENTATIVE. HOWEVER, THE CUSTOMER HAD TO CHANGE 2 CATHETERS AS THEY WERE STILL COMING OFF, AND THE PATIENT WAS GETTING WET. ON (B)(6) 2022, THE CUSTOMER STATED THAT THE PATIENT WAS NOT ABLE TO GET INTO THEIR CHAIR BECAUSE THEY KEPT GETTING WET AND HAD TO STAY IN BED. THE CUSTOMER COULD NOT GO OUT BECAUSE THEY HAD TO MAKE SURE TO KEEP CHANGING THE PATIENT'S CATHETER AND CLEAN THEM SO THAT THEY DO NOT GET INFECTIONS. THEY COULD NOT GO OUT BECAUSE THE CATHETERS KEPT LEAKING. AS PER FOLLOW-UP INFORMATION RECEIVED ON 27JAN2023, STATED THAT BOTH OF

  Patient problems: Pressure Sore/Ulcer; Tissue Breakdown

  MAUDE report 16272256 ↗
• MalfunctionApr 24, 2020Nonstandard Device; Nonstandard Device; Material Integrity Problem

  IT WAS REPORTED THAT THE MEC HAD TOO MUCH ADHESIVE, THE PATIENT NOTED THAT THEY EXPERIENCED PAIN DURING REMOVAL. THE PATIENT ALSO NOTED THAT HE SOAKED IN TUB FOR AN HOUR AND WAS STILL NOT ABLE TO REMOVE ALL OF THE ADHESIVE. THE PATIENT STATED THAT IT WAS LIKE REMOVING A LAYER OF SKIN BUT CURRENTLY UNABLE TO SEE THE DOCTOR.

  Patient problems: No Consequences Or Impact To Patient; Pain

  MAUDE report 9995148 ↗
• MalfunctionOct 8, 2019Nonstandard Device; Product Quality Problem; Nonstandard Device

  IT WAS REPORTED THAT THE GLUE ON THE MALE EXTERNAL CATHETER WAS STRONG WHICH MADE THE CATHETER DIFFICULT TO REMOVE.

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

  MAUDE report 9165859 ↗
• MalfunctionSep 5, 2019Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS VERY STICKY AND HARD TO GET OFF. THE COMPLAINANT REPORTEDLY REMOVED THE CATHETER BY PULLING IT OFF SLOWLY. THE CATHETER REPORTEDLY TOOK ABOUT 45 MINUTES TO BE REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8966376 ↗
• MalfunctionJul 9, 2018Nonstandard Device; Material Integrity Problem; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER TESTED ABOVE THE SPECIFICATION FOR STRONG ADHESIVE.

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

  MAUDE report 7671258 ↗
• MalfunctionDec 11, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE ADHESIVE ON THE CATHETER WAS TOO STRONG. THE COMPLAINANT ALLEGED THAT THE STRONG ADHESIVE CAUSED PULLING ON THE SKIN WHEN TRYING TO REMOVE THE CATHETER WHICH CAUSED SOME IRRITATION AND SELF-LIMITED BLEEDING. ALLEGEDLY, OVER THE COUNTER MEDICATION WAS USED FOR TREATMENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Irritation

  MAUDE report 7103944 ↗
• MalfunctionJun 5, 2017No Device Output

  IT WAS REPORTED THAT THE CATHETER DID NOT DRAIN URINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6613191 ↗