Spirit® Hydrocolloid Adhesive Sheath 35104Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741070907), received between May 2, 2018 and Sep 23, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT CUSTOMER NOTICED SWELLING IN THE PATIENT¿S GROIN AREA ON (B)(6) 2021. PATIENT HAD TREATED WITH ANTIBIOTICS AND CREAM TO MAKE THE SWELLING GO DOWN. CUSTOMER USED PRODUCT ONCE AGAIN AND NOTICED THERE WAS NO ADHESIVENESS. NOTED THIS ISSUE HAD OCCURRED MULTIPLE TIMES.

  Patient problems: Swelling/ Edema

  MAUDE report 12521226 ↗
• MalfunctionOct 15, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE WAS STICKING TO THE SKIN AND HAIR AFTER THE CATHETER WAS REMOVED. IT WAS ALSO REPORTED THAT THE ADHESIVE DID NOT REMOVE EVEN AFTER SHOWERING WITH HOT WATER AND SOAP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10681951 ↗
• MalfunctionApr 20, 2020Nonstandard Device; Physical Resistance/Sticking; Nonstandard Device

  IT WAS REPORTED THAT THE CATHETER HAD VERY STRONG ADHESIVE. THE CATHETER WAS PULLING UP THE PATIENT¿S DRY SKIN CAUSING TENDERNESS WITHOUT BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 9977867 ↗
• MalfunctionMay 23, 2018Nonstandard Device; Difficult to Remove; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS DIFFICULT TO REMOVE DUE TO THE ADHESIVE BEING TOO STRONG. THE PATIENT STATED THAT HE HAD TO "CUT OFF THE CATHETER". NO PATIENT INJURY REPORTED. NO MEDICAL INTERVENTION REQUIRED.

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

  MAUDE report 7536429 ↗
• MalfunctionMay 2, 2018Nonstandard Device; Nonstandard Device; Device Operates Differently Than Expected

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

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Peeling; Skin Tears

  MAUDE report 7479743 ↗