Spirit® Hydrocolloid Adhesive Sheath 37301Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741071171), received between May 20, 2019 and Jun 3, 2022 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN GETTING A LOT OF URINARY TRACT INFECTIONS (UTI¿S). DOCTOR SAID TO PATIENT TO DISCONTINUE EXTERNAL USAGE DUE TO MULTIPLE URINARY TRACT INFECTIONS (UTI¿S). IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTIONS AND IF THE MALE EXTERNAL CATHETER CONTRIBUTED TO URINARY TRACT INFECTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 14594695 ↗
• MalfunctionJun 1, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETER WAS TOO HARD ON THE PATIENT'S SKIN. THE REPRESENTATIVE ADVISED THE CUSTOMER THAT THERE WAS A SAMPLE CONDOM CATHETER SIMILAR TO THE ONE THEY WERE USING BUT MIGHT BE THE ADHESIVE WOULD WORK BETTER WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14565192 ↗
• MalfunctionMay 26, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE CUSTOMER WAS USING THE MALE EXTERNAL CATHETERS AND THEY WERE BREAKING. THE CUSTOMER HAD BROKEN TWO CATHETERS AS OF NOW. ALSO DESCRIBED THAT THE ADHESIVE KEPT STICKING AND IT TORE WHEN THE CUSTOMER TRIED TO GET IT UNSTUCK. THE CAREGIVER SUGGESTED THAT THE CUSTOMER NEEDED A LARGER SIZE OF THE MALE EXTERNAL CATHETER. PER CUSTOMER VIA PHONE ON (B)(6) 2021, CUSTOMER STATED THAT MALE EXTERNAL CATHETER WAS STICKING ITSELF AND TO THE CUSTOMER AND HAD TROUBLE GETTING THEM ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11886987 ↗
• MalfunctionJan 6, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS IN THE LAST ORDER WERE TOO STICKY AND HARD TO TAKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11123836 ↗
• MalfunctionOct 9, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THERE WAS TOO MUCH ADHESIVE IN THE MALE EXTERNAL CATHETER AS A RESULT THE PATIENT COULD NOT GET THE EXTERNAL ON BECAUSE IT STUCK TOGETHER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10657219 ↗
• InjuryMar 26, 2020Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A (UTI) URINARY TRACT INFECTION WHILE USING THE MALE EXTERNALS. IT WAS NOTED THAT THE PATIENT CLEANED THE MALE EXTERNAL AND THE DRAIN BAG WITH VINEGAR. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 9886142 ↗
• MalfunctionMar 25, 2020Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Nonstandard Device

  IT WAS REPORTED THAT THE EXTERNALS PULLED OFF HIS SKIN WHEN HE REMOVED THEM. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Tears

  MAUDE report 9877862 ↗
• InjuryFeb 26, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT WAS IN THE ICU DUE TO A BAD UTI HE GOT FROM USING THE MALE EXTERNAL CATHETER. THE PATIENT'S DOCTOR REPORTEDLY ADVISED HIM TO DISCONTINUE USE OF THE CATHETERS BECAUSE HE ALLEGEDLY ALMOST DIED.

  Patient problems: Urinary Tract Infection

  MAUDE report 9758957 ↗
• MalfunctionAug 5, 2019Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE WAS TOO STRONG AND AS A RESULT THE PATIENT "HURT HIMSELF" WHEN REMOVING THEM.

  Patient problems: Pain

  MAUDE report 8861895 ↗
• MalfunctionJul 8, 2019Nonstandard Device; Nonstandard Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER ADHESIVE WAS TOO STRONG CAUSING SKIN TEARS UPON REMOVAL.

  Patient problems: Abrasion; Skin Tears

  MAUDE report 8768868 ↗
• MalfunctionMay 20, 2019Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE CATHETHER HAD TOO MUCH ADHESIVE. THE PATIENT ADVISED THAT THE ADHESIVE MADE IT UNCOMFORTABLE TO USE THE CATHETERS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8624359 ↗