Spirit® Hydrocolloid Adhesive Sheath 35301Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741070921), received between Mar 1, 2019 and May 12, 2023 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT STATED THAT THIS ISSUE HAS BEEN GOING ON FOR ABOUT THREE MONTHS AND THE PATIENT WAS STILL HAVING WHEN REMOVING. THE PATIENT¿S SKIN BECAME SENSITIVE AND IRRITATED. THE PATIENT STATED THAT THEIR DOCTOR GAVE A MATERIAL TO PUT ON THEIR PENIS FOR A COUPLE OF WEEKS AND NOW IT IS REALLY RED. THE PATIENT HAD BEEN USING A BLOW DRYER FOR THE PAST FIVE WEEKS TO KEEP THE CONDOM CATHETER ON. IT WAS STATED THAT THE PATIENT WAS THINKING THAT WITH WASHING, THEY WOULD BE OK.

  Patient problems: Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 16918222 ↗
• InjuryNov 18, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT LEG BAG VALVE WAS LEAKED. PER FOLLOW UP VIA PHONE ON 17 OCT 2022, IT WAS REPORTED THAT THE TUBE LEADING TO THE LEG BAG HAD A STICKY RESIDE ON IT DUE TO PATIENT USING SURGICAL TAPE ON IT TO KEEP IT IN PLACE. PATIENT ALSO STATED THAT THEY HAVE DEVELOPED A RASH ON THEIR PENIS FROM THE MALE EXTERNAL CATHETER AND THEY HAD NOT SOUGHT MEDICAL ATTENTION BUT WAS APPLYING CREAM TO HELP WITH THE IRRITATION. AND STATED THAT THE ADHESIVE WAS PEELING THE SKIN OFF OF THEIR PENIS. NO MEDICAL INTERVENTION WAS REPORTED. PER NOTIFICATION FROM UCC ON (B)(6) 2022, ADDITIONAL USED SAMPLE WAS RETURNED FOR PCN#35301.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 15825346 ↗
• InjuryNov 1, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT LEG BAG VALVE WAS LEAKED. AS PER FOLLOW UP VIA PHONE ON (B)(6) 2022, IT WAS REPORTED THAT THE TUBE LEADING TO THE LEG BAG HAD A STICKY RESIDE ON IT DUE TO PATIENT USING SURGICAL TAPE ON IT TO KEEP IT IN PLACE. PATIENT ALSO STATED THAT THEY HAVE DEVELOPED A RASH ON THEIR PENIS FROM THE MALE EXTERNAL CATHETER AND THEY HAD NOT SOUGHT MEDICAL ATTENTION BUT WAS APPLYING CREAM TO HELP WITH THE IRRITATION. AND STATED THAT THE ADHESIVE WAS PEELING THE SKIN OFF OF THEIR PENIS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 15708141 ↗
• MalfunctionAug 2, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE DIFFICULT TO PUT ON (MATERIAL#35301) (MATERIAL# 35302) AND TAKE OFF (MATERIAL#35301)AND (MATERIAL# 35302).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15150351 ↗
• MalfunctionJun 27, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT PUT ON A SAMPLE MALE EXTERNAL CATHETER CATHETER AND NOW THEY COULD NOT GET IT OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14835097 ↗
• MalfunctionMay 13, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETER WAS TOO STICKY AND THEY WERE DIFFICULT TO REMOVE. ALSO STATED THAT THE LEG BAGS WERE NOT WORKING FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820066 ↗
• MalfunctionFeb 4, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WAS HAVING DIFFICULTY IN REMOVING THESE MALE EXTERNAL CATHETER AND THE ADHESIVE WAS HURTING. LIBERATOR REPRESENTATIVE RECOMMENDED THE PATIENT REMOVE THE MALE EXTERNAL CATHETER IN THE SHOWER OR WITH A WASHCLOTH AND WARM WATER.

  Patient problems: Pain

  MAUDE report 11280553 ↗
• MalfunctionFeb 1, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS DID NOT HAVE ADHESIVE. PER FOLLOW UP THE CUSTOMER NOTED THAT THE PROBLEM WITH THE ITEM 35301 WAS TOO MUCH ADHESIVE ON THE CATHETER WHICH MADE THE CATHETER DIFFICULT TO REMOVE FROM THE PATIENT. THE CUSTOMER CONFIRMED THAT THE CATHETERS WERE NOT STICKING ARE FROM THE COLOPLAST AND NOT BARD OR BD.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11263787 ↗
• MalfunctionMar 12, 2020Nonstandard Device; Inadequacy of Device Shape and/or Size; Nonstandard Device

  IT WAS REPORTED THAT THE SAMPLES SENT WERE TOO SMALL AND CAUSED SOME PAIN; THEY PATIENT ALSO NOTED THAT THEY WERE PAINFUL TO REMOVE.

  Patient problems: No Consequences Or Impact To Patient; Pain

  MAUDE report 9824720 ↗
• MalfunctionSep 4, 2019Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MEC WAS DIFFICULT TO REMOVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8962182 ↗
• MalfunctionMar 1, 2019Nonstandard Device; Difficult to Remove; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETERS WAS TOO STRONG AND VERY DIFFICULT TO REMOVE. THE PATIENT INDICATED THAT HIS SKIN WAS IRRITATED AND DRY. THE PATIENT'S WIFE ADVISED VIA PHONE ON 2019, THAT THE REMOVAL TECHNIQUES SHE WAS OFFERED WORKED WELL. HOWEVER, HER HUSBAND'S SKIN WAS STILL DRY BUT WAS GETTING BETTER.

  Patient problems: Discomfort; Skin Irritation

  MAUDE report 8383194 ↗