Spirit® Hydrocolloid Adhesive Sheath 39102Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741071287), received between Oct 4, 2017 and Oct 2, 2018 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2018Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS DIFFICULT TO UNROLL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7926469 ↗
• MalfunctionAug 8, 2018Labelling, Instructions for Use or Training Problem; Component Missing; Component Missing

  IT WAS REPORTED THAT THE CATHETER DID NOT COME WITH THE INSTRUCTIONS FOR USE.

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

  MAUDE report 7763095 ↗
• InjuryJun 20, 2018Patient-Device Incompatibility; Device Operates Differently Than Expected; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT'S DOCTOR ALLEGEDLY BELIEVED THAT THE MALE EXTERNAL CATHETERS MAY HAVE CONTRIBUTED TO THE PATIENT DEVELOPING A BLADDER INFECTION, FOR WHICH THE PATIENT WAS HOSPITALIZED. IT WAS REPORTED THAT THE PATIENT HAD BEEN RECEIVING ANTIBIOTICS THROUGH A PICC LINE EVERY EIGHT HOURS FOR TWO WEEKS TO TREAT THE BLADDER INFECTION. IT WAS REPORTED THAT THE PATIENT DISCONTINUED USE OF THE MALE EXTERNAL CATHETERS AFTER DIAGNOSIS OF THE BLADDER INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7621522 ↗
• InjuryApr 23, 2018Patient-Device Incompatibility; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STAGE 3 PRESSURE SORE WAS OBSERVED AT THE BASE OF THE PATIENT'S PENIS AFTER USING THE MALE EXTERNAL CATHETER. THE COMPLAINANT REPORTED THAT THIS WAS TREATED WITH PRESCRIBED MEDICATION. CLINICAL STATEMENT: PER REPORTABILITY GUIDELINES, IT HAS BEEN DETERMINED THAT THIS TYPE OF EVENT HAS CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. IT IS LIKELY THAT THIS TYPE OF INJURY MAY REQUIRE MEDICAL INTERVENTION, ALTHOUGH NOT REPORTED AT THIS TIME. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION PROVIDED REGARDING THE REPORTED ADDITIONAL MEDICAL TREATMENT OF PRESCRIBED MEDICATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT AND REPORTABILITY WILL BE UPDATED ACCORDINGLY.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 7452679 ↗
• InjuryApr 23, 2018Patient-Device Incompatibility; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STAGE 3 PRESSURE SORE WAS OBSERVED AT THE BASE OF THE PATIENT'S PENIS AFTER USING THE MALE EXTERNAL CATHETER. THE COMPLAINANT REPORTED THAT THIS WAS TREATED WITH PRESCRIBED MEDICATION. CLINICAL STATEMENT: PER REPORTABILITY GUIDELINES, IT HAS BEEN DETERMINED THAT THIS TYPE OF EVENT HAS CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. IT IS LIKELY THAT THIS TYPE OF INJURY MAY REQUIRE MEDICAL INTERVENTION, ALTHOUGH NOT REPORTED AT THIS TIME. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION PROVIDED REGARDING THE REPORTED ADDITIONAL MEDICAL TREATMENT OF PRESCRIBED MEDICATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT AND REPORTABILITY WILL BE UPDATED ACCORDINGLY.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 7452583 ↗
• InjuryApr 23, 2018Patient-Device Incompatibility; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STAGE 3 PRESSURE SORE WAS OBSERVED AT THE BASE OF THE PATIENT'S PENIS AFTER USING THE MALE EXTERNAL CATHETER. THE COMPLAINANT REPORTED THAT THIS WAS TREATED WITH PRESCRIBED MEDICATION. CLINICAL STATEMENT: PER REPORTABILITY GUIDELINES, IT HAS BEEN DETERMINED THAT THIS TYPE OF EVENT HAS CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. IT IS LIKELY THAT THIS TYPE OF INJURY MAY REQUIRE MEDICAL INTERVENTION, ALTHOUGH NOT REPORTED AT THIS TIME. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION PROVIDED REGARDING THE REPORTED ADDITIONAL MEDICAL TREATMENT OF PRESCRIBED MEDICATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT AND REPORTABILITY WILL BE UPDATED ACCORDINGLY.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 7452577 ↗
• InjuryApr 23, 2018Patient-Device Incompatibility; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STAGE 3 PRESSURE SORE WAS OBSERVED AT THE BASE OF THE PATIENT'S PENIS AFTER USING THE MALE EXTERNAL CATHETER. THE COMPLAINANT REPORTED THAT THIS WAS TREATED WITH PRESCRIBED MEDICATION. CLINICAL STATEMENT: PER REPORTABILITY GUIDELINES, IT HAS BEEN DETERMINED THAT THIS TYPE OF EVENT HAS CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. IT IS LIKELY THAT THIS TYPE OF INJURY MAY REQUIRE MEDICAL INTERVENTION, ALTHOUGH NOT REPORTED AT THIS TIME. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION PROVIDED REGARDING THE REPORTED ADDITIONAL MEDICAL TREATMENT OF PRESCRIBED MEDICATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT AND REPORTABILITY WILL BE UPDATED ACCORDINGLY.

  Patient problems: Injury; Pressure Sore/Ulcer

  MAUDE report 7452503 ↗
• MalfunctionDec 5, 2017Incorrect Device Or Component Shipped

  IT WAS REPORTED THAT THE COMPLAINANT RECEIVED A BOX FOR PRODUCT CATALOG NUMBER 39102 WITH CORPORATE LOT NUMBER JUBT1749; HOWEVER, THAT THE PRODUCT WITHIN THE BOX WAS FOR PRODUCT CATALOG NUMBER 37104 WITH CORPORATE LOT NUMBER JUBT1749.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7082535 ↗
• MalfunctionNov 14, 2017Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE COMPLAINANT RECEIVED A BOX FOR PRODUCT CATALOG NUMBER 39102 WITH CORPORATE LOT NUMBER JUBT1749 AND THAT THE PRODUCT WITHIN THE BOX WAS PRODUCT CATALOG NUMBER 37104 WITH CORPORATE LOT NUMBER JUBT1749.

  Patient problems: No Information

  MAUDE report 7027336 ↗
• 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 Information

  MAUDE report 7000699 ↗
• MalfunctionOct 31, 2017Incorrect Device Or Component Shipped

  IT WAS REPORTED THAT THE COMPLAINANT RECEIVED A BOX FOR PRODUCT CATALOG NUMBER 39102 WITH CORPORATE LOT NUMBER JUBT1749; HOWEVER, THE PRODUCT WITHIN THE BOX WAS PRODUCT CATALOG NUMBER 37104 WITH CORPORATE LOT NUMBER JUBT1749.

  Patient problems: No Information

  MAUDE report 6990050 ↗
• MalfunctionOct 4, 2017Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO REMOVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6913477 ↗