Spirit® Hydrocolloid Adhesive Sheath 35101Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741070877), received between Mar 16, 2019 and Sep 9, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS HAD TOO MUCH ADHESIVE AND THE PATIENT EXPERIENCED SKIN BREAK OUT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12448064 ↗
• MalfunctionApr 20, 2020Nonstandard Device; Difficult to Remove; Nonstandard Device

  IT WAS REPORTED THAT HE PATIENT WAS HAVING A DIFFICULT TIME REMOVING THE MALE EXTERNAL CATHETER. THE PATIENT REPORTED THAT SOME SKIN BECAME RAW WITH SORES DUE TO HOW DIFFICULT IT WAS TO REMOVE. WARM CLOTHS, BATHS, AND EVEN ADHESIVE REMOVERS WERE USED, HOWEVER THERE WAS RESIDUE LEFT BEHIND THAT WAS DIFFICULT TO REMOVE.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 9978100 ↗
• MalfunctionMar 16, 2019Nonstandard Device; Therapeutic or Diagnostic Output Failure; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE OF THE MALE EXTERNAL CATHETER WAS TOO STRONG AND ALLEGEDLY CAUSED THE PATIENT PAIN. NO PATIENT INJURY/MEDICAL INTERVENTION REPORTED.

  Patient problems: Pain

  MAUDE report 8426528 ↗