Spirit® Hydrocolloid Adhesive Sheath 39301Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741071324), received between Jul 16, 2019 and Jun 14, 2023 — classified as 1 injury, 8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THESE MALE EXTERNAL CATHETERS CAUSED SORES ON TIP AND SHAFT OF PENIS. THE PATIENT STATED THAT THE ADHESIVE REMOVED THE SKIN OFF. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Inflammation/ Irritation; Skin Tears

  MAUDE report 17124782 ↗
• MalfunctionFeb 3, 2023Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT THE PATIENT HAD RECEIVED A BOX OF MALE EXTERNAL CATHETER WITH LOT# JUGY0417 AND REFERENCE# 39301 WITH THE INDIVIDUAL PACKAGE LOT# JGW9027. THE PATIENT HAD PUT ONE OF THEM ON AND STATED THAT THE CATHETER HAD SHREDDED APART WHILE IT WAS GETTING PUT ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16291170 ↗
• MalfunctionAug 17, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS TOO HARD TO TAKE OFF. PER FOLLOW UP ON 29JUL21021, PATIENT EXPERIENCED SKIN PEELED OFF WHEN REMOVING THE CATHETER. PATIENT HAD USED THE EXTERNAL CATHETER MORE THAN 90 DAYS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Tears

  MAUDE report 12333549 ↗
• MalfunctionSep 23, 2020Nonstandard Device; Physical Resistance/Sticking; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD A TROUBLE BY USING MALE EXTERNAL CATHETER, BECAUSE IT WAS TOO AGGRESSIVE WITH THE ADHESIVE.

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

  MAUDE report 10572937 ↗
• MalfunctionMay 20, 2020Nonstandard Device; Nonstandard Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ADHESIVE ON THE EXTERNALS WAS TOO STICKY AND WOULD STICK TO THE FINGERS SO THE PATIENT COULDN¿T GET THEM ON. IT WAS NOTED THAT THE CATHETER WOULD KINK NOT ALLOWED URINE TO FLOW.

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

  MAUDE report 10074253 ↗
• MalfunctionDec 5, 2019Nonstandard Device; Nonstandard Device; Defective Device

  IT WAS REPORTED THAT THE MALE CATHETER HAD TOO MUCH ADHESIVE. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 9415736 ↗
• MalfunctionNov 22, 2019Nonstandard Device; Nonstandard Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SAID HE LOST SKIN REMOVING THE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; Skin Tears

  MAUDE report 9364751 ↗
• InjuryJul 19, 2019Patient-Device Incompatibility; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS CONTINUOUSLY GETTING URINARY TRACT INFECTIONS WHILE USING THE MALE EXTERNAL CATHETER.

  Patient problems: Urinary Tract Infection

  MAUDE report 8809125 ↗
• MalfunctionJul 16, 2019Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON THE MEC WAS TOO STRONG AND CAUSED THE PATIENT'S SKIN TO BLEED UPON REMOVAL. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8793810 ↗