Spirit® Hydrocolloid Adhesive Sheath 39305Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741071362), received between Sep 30, 2019 and Jun 25, 2025 — classified as 3 injuries, 5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT OVER THE LAST EIGHT MONTHS DEVELOPED SKIN IRRITATION. DID CONSULTED PRIMARY CARE PHYSICIAN WHO PRESCRIBED MEDICATION.

  Patient problems: Skin Inflammation/ Irritation; Tissue Breakdown; Urinary Tract Infection

  MAUDE report 22331771 ↗
• MalfunctionFeb 27, 2023Nonstandard Device; Patient Device Interaction Problem; Nonstandard Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT FELT A LAYER OF SKIN WAS COMING OFF TOO ,WHEN THE MALE EXTERNAL CATHETER TOOK IT OFF FROM PENIS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Tears

  MAUDE report 16443171 ↗
• MalfunctionNov 30, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS HARD TO REMOVE DUE TO ALL THE ADHESIVE THAT RUNS THROUGH THE SHEATH. THEY STATED THAT IT SOMETIMES TAKES THE SKIN OFF THE BOTTOM OF THEIR PENIS. PER ADDITIONAL INFORMATION RECEIVED VIA LIBERATOR ON 14-NOV-2022, STATED THAT THESE MALE EXTERNAL CATHETERS PULL AT SKIN AND MADE IT SORENESS TO THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 15887786 ↗
• MalfunctionSep 23, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS HARD TO REMOVE DUE TO ALL THE ADHESIVE THAT RUNS THOUGH THE SHEATH. THEY STATED THAT IT SOMETIMES TAKES THE SKIN OFF THE BOTTOM OF THEIR PENIS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Tears

  MAUDE report 15469493 ↗
• MalfunctionFeb 28, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESION IN THE MALE EXTERNAL CATHETER WAS REALLY STRONG. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620810 ↗
• InjuryDec 30, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE DOCTOR ADVISED THE PATIENT THAT THE URINARY TRACT INFECTION MIGHT BE DUE TO THE MALE EXTERNAL CATHETER. IT WAS UNKNOWN THAT WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 13119161 ↗
• InjuryFeb 28, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER CAUSED THE PATIENT TO BREAK OUT AND GAVE HIM AN INFECTION.

  Patient problems: Reaction; Unspecified Infection

  MAUDE report 9769588 ↗
• MalfunctionSep 30, 2019Nonstandard Device; Difficult to Remove; Nonstandard Device

  IT WAS REPORTED THAT THE MECS ADHESIVE WAS TOO STRONG, WHICH MADE THEM DIFFICULT TO REMOVE. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 9134436 ↗