Spirit® Hydrocolloid Adhesive Sheath 37103Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741071140), received between Apr 26, 2017 and Sep 25, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2018Material Deformation

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS KNOTTED AT THE END.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7906612 ↗
• MalfunctionMar 27, 2018Nonstandard Device; Nonstandard Device; Difficult to Remove; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETER WAS TOO STRONG, AND MADE IT DIFFICULT TO REMOVE.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7372778 ↗
• MalfunctionMar 23, 2018Nonstandard Device; Nonstandard Device; Material Integrity Problem

  IT WAS REPORTED THAT THE ADHESIVE OF THE MALE EXTERNAL CATHETER WAS TOO STRONG AND THE PATIENT EXPERIENCED SELF-LIMITED BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 7367371 ↗
• MalfunctionMay 18, 2017Difficult to Remove

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS DIFFICULT TO REMOVE, ALLEGEDLY DUE TO EXCESSIVE ADHESIVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6576902 ↗
• MalfunctionMay 2, 2017Difficult to Remove

  IT WAS REPORTED THAT THE ADHESIVE WAS VERY STRONG MAKING THE CATHETER DIFFICULT TO REMOVE. IT ALLEGEDLY TOOK THE COMPLAINANT 20 MINUTES TO REMOVE THE CATHETER FROM THE PATIENT'S PENIS; HOWEVER, NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6536830 ↗
• MalfunctionApr 26, 2017Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO REMOVE FROM THE PATIENT'S SKIN CAUSING SOME RED SPOTS DUE TO "TUGGING" THE CATHETER OFF. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Skin Irritation

  MAUDE report 6524837 ↗