Spirit® Hydrocolloid Adhesive Sheath 37304Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741071201), received between May 15, 2018 and Oct 6, 2022 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETER WAS VERY DIFFICULT TO TAKE OFF AND IT IRRITATES THE SKIN. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 15551118 ↗
• MalfunctionFeb 28, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WAS PUTTING ON THE MALE EXTERNAL CATHETER ADHESION STUCK TO THEIR FORESKIN. THE PATIENT STATED NO BLEEDING BUT IT WAS RAW. NO MEDICAL INTERVENTION WAS REQUIRED

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Local Reaction

  MAUDE report 13625906 ↗
• MalfunctionApr 20, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD ISSUES WITH REMOVING THE MALE EXTERNAL CATHETER WITH THE BATCH. PER FOLLOW UP CALL ON 04JUN2021 IT WAS STATED BY THE CUSTOMER THAT THE CATHETERS WERE HARDER TO GET OFF THAN THE OLDER ONES AND HAD TO POWDERED THEMSELVES BEFORE PUTTING THEM ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11695722 ↗
• MalfunctionJan 31, 2020Nonstandard Device; Defective Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT STATED THE CATHETER DON¿T WORK FOR HIM; THEY WON¿T COME OFF.

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

  MAUDE report 9652830 ↗
• InjuryJun 11, 2019Inaccurate Flow Rate; Inaccurate Flow Rate; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD 3 WATER BLISTERS AT THE TIP, POSSIBLY DUE TO THE URINE NOT COMPLETELY DRAINING FROM THE MALE EXTERNAL CATHETER. THE PATIENT REPORTEDLY WENT TO THE DOCTOR WHERE HE WAS ADVISED TO USE BACITRACIN ON THE BLISTERS. THE PATIENT REPORTEDLY ALSO DEVELOPED A URINARY TRACT INFECTION AND HAD TO GO TO THE HOSPITAL.

  Patient problems: Patient Problem/Medical Problem; Urinary Tract Infection

  MAUDE report 8687520 ↗
• InjuryMar 18, 2019Backflow; Nonstandard Device; Inadequacy of Device Shape and/or Size; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS TOO NARROW WHERE IT CONNECTS TO THE PATIENT TUBING; AND ALLOWS URINE TO FLOW BACK INTO THE CATHETER. THE PATIENTS ALLEGED THAT UTI (URINARY TRACT INFECTIONS) HAVE OCCURRED DURING THE USE OF THE MALE EXTERNAL CATHETER. IT IS UNKNOWN AT THIS TIME IF TREATMENT WAS RECEIVED FOR THE URINARY TRACT INFECTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 8429674 ↗
• MalfunctionDec 28, 2018Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETER WAS TOO STRONG. THE PATIENT ALLEGEDLY EXPERIENCED SKIN IRRITATION. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Skin Irritation

  MAUDE report 8204162 ↗
• MalfunctionNov 16, 2018Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT USES A LIQUID SKIN PROTECTANT WITH THE MALE EXTERNAL CATHETER BUT UPON REMOVAL OF THE CATHETER, THE ADHESIVE GETS CAUGHT AT THE END OF THE PATIENT'S PENIS CAUSING SKIN PEELING AND SELF LIMITED BLEEDING. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Skin Tears

  MAUDE report 8081972 ↗
• MalfunctionJun 19, 2018Nonstandard Device; Difficult to Remove; Device Operates Differently Than Expected; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETER WAS TOO STRONG, AND MADE IT DIFFICULT TO REMOVE FROM THE SKIN. IT WAS REPORTED THAT THE PATIENT USED A WARM COMPRESS, WHICH HELPED TO REMOVE THE CATHETER.

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

  MAUDE report 7614346 ↗
• MalfunctionMay 15, 2018Nonstandard Device; Nonstandard Device; Sticking

  IT WAS REPORTED THAT DURING THE INVESTIGATION OF ANOTHER EVENT, THREE OF THE SAMPLES WERE ABOVE THE SPECIFICATION FOR ADHESIVE STRENGTH.

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

  MAUDE report 7514051 ↗