Spirit® Hydrocolloid Adhesive Sheath 35102Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741070884), received between Nov 3, 2017 and Nov 13, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2018Nonstandard Device; Nonstandard Device; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT THE ADHESIVE OF THE MALE EXTERNAL CATHETER WAS STRONGER THAN USUAL AND THE PATIENT THEREFORE EXPERIENCED DIFFICULTY REMOVING THE CATHETER. NO MEDICAL INTERVENTION REPORTED.

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

  MAUDE report 8066149 ↗
• MalfunctionJul 10, 2018Nonstandard Device; Material Integrity Problem; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETERS WAS TOO STRONG, MAKING THEM DIFFICULT TO REMOVE EVEN WHEN ROLLING OFF AND USING A WARM, MOIST COMPRESS. IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED PAIN WHILE TRYING TO REMOVE THE MALE EXTERNAL CATHETER. THERE WAS NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Pain

  MAUDE report 7675391 ↗
• MalfunctionDec 6, 2017Difficult to Remove

  IT WAS REPORTED THAT THE ADHESIVE OF THE MALE EXTERNAL CATHETER WAS STRONGER THAN USUAL. THE COMPLAINANT REPORTED THAT THE PATIENT HAD THE MALE EXTERNAL CATHETER ON FOR ABOUT 12 HOURS AND EXPERIENCED DIFFICULTY REMOVING IT FROM HIS SKIN AFTER. THE PATIENT ALLEGEDLY ATTEMPTED TO SOAK IN THE TUB AND WAS ABLE TO REMOVE THE EXTERNAL CATHETER BUT EXPERIENCED PAIN AND ABRASIONS ON HIS PENIS. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Abrasion; Pain

  MAUDE report 7087471 ↗
• MalfunctionNov 3, 2017Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CATHETER WAS A SIZE 36MM INSTEAD OF 29MM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7000590 ↗