Spirit® Hydrocolloid Adhesive Sheath 35302Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00801741070938), received between Jun 6, 2017 and Mar 16, 2023 — classified as 2 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (27 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT ALL OF THE MALE EXTERNAL CATHETERS WERE DIFFICULT TO REMOVE AS THE ADHESIVE WOULD NOT LET GO AND CAUSED SEVERE IRRITATION WHEN IT REMOVED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 16551991 ↗
• MalfunctionMar 13, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE DIFFICULT TO REMOVE AS THE ADHESIVE WOULD NOT LET GO AND IT CAUSED SEVERE IRRITATION WHEN IT REMOVED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 16529405 ↗
• MalfunctionDec 4, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE LEAKING AND DID NOT HOLD. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 25OCT2022, STATED THAT 54 CATHETERS WERE RECEIVED FROM THE PATIENT. THE PATIENT HAD BEEN USING MALE EXTERNAL CATHETERS FOR OVER 7 YEARS AND THERE HAD BEEN NO PROBLEMS WITH THEM SO FAR. THE PATIENT WAS COMPLETELY PARALYZED, THEY WERE LYING DOWN, OR USED A SPECIALLY ADAPTED WHEELCHAIR AND THE CARER OF THIS PATIENT REPORTED THE PROBLEM WITH CATHETERS. PER NOTIFICATION FROM INVESTIGATOR ON 17NOV2022, DURING SAMPLE EVALUATION STRONG ADHESIVE WAS FOUND WHILE TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15912602 ↗
• MalfunctionSep 15, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT ADHESIVE ON MALE EXTERNAL CATHETER DID NOT ABLE TO REMOVE EASILY. THE REPRESENTATIVE ADVISED PATIENT WOULD NEED TO LET THE ADHESIVE BREAK DOWN TO AVOID DIFFICULT REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15429401 ↗
• MalfunctionAug 9, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETER DID NOT STAY ON AND CAUSED A MESS AT NIGHT AND ALSO CREATED A MESS TO REMOVE THE CATHETERS. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW-UP VIA PHONE ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE BLEEDING AND THE CUSTOMER STATED THE ADHESIVE WAS WEARING OFF WHEN THEY PEED, CREATING A MESS OF URINE. THE CUSTOMER STATED THEY WERE STILL ABLE TO DRAIN THEIR BLADDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15192435 ↗
• MalfunctionAug 9, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT SAID MALE EXTERNAL CATHETERS WERE LIKE PULLING ON A ROPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15190434 ↗
• MalfunctionAug 2, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE DIFFICULT TO PUT ON (MATERIAL#35301) (MATERIAL# 35302) AND TAKE OFF (MATERIAL#35301) (MATERIAL# 35302).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15150475 ↗
• MalfunctionJun 1, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE PAINFUL TO REMOVE EVEN WITH SOAPY WATER AND VASELINE. IT WAS STATED THAT THE PATIENT EXPERIENCED SORENESS AND HAD PAIN. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 14564519 ↗
• MalfunctionMay 9, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD TROUBLE GETTING OFF ALL OF THE ADHESIVE FROM THE MALE EXTERNAL CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14338311 ↗
• InjuryFeb 1, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED URINARY TRACT INFECTION BY USING THE MALE EXTERNAL CATHETERS AND THE CAUSE WAS UNKNOWN. THE PATIENT SOUGHT MEDICAL ATTENTION AND RECEIVED ANTIBIOTIC FOR THE UTI. THE PATIENT HAD BEEN USING PRODUCTS FOR MORE THAN 90 DAYS.

  Patient problems: Urinary Tract Infection

  MAUDE report 13416860 ↗
• MalfunctionJan 14, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD ISSUES WITH GETTING THE MALE EXTERNAL CATHETER OFF DUE TO THE ADHESIVE. THE REPRESENTATIVE ADVISED TO GET A WARM TOWEL AND HOLD IT IN PLACE FOR ONE MINUTE BUT RECOMMENDED FOR TWO OR THREE MINUTES TO MAKE SURE THAT THE REMOVAL OF THE CATHETERS WOULD BE BETTER. THE PATIENT HAD BEEN USING THE PRODUCTS FOR LESS THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13257769 ↗
• MalfunctionOct 29, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT TRIED USING A 29MM MALE EXTERNAL CATHETER AND IT GOT STUCK. THE PATIENT COULD NOT GET THE CATHETER OFF AND THOUGHT THAT THEY HAD TO GO TO THE EMERGENCY ROOM. ALSO STATED THAT THE PATIENT HAD PAIN IN THE PENIS FOR SEVERAL DAYS AFTER. THE MENTIONED CATALOG NUMBERS ARE 35302, 37302 AND 39302. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 12724209 ↗
• MalfunctionJul 1, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN TEARING AND BLEEDING WHEN REMOVING THE MALE EXTERNAL CATHETER. THE PATIENT STATED THAT THIS HAPPENED DUE TO THE TOO AGGRESSIVE ADHESIVE STICKING. REPRESENTATIVE SUGGESTED TO TRY BARRIER CREAM. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 12104411 ↗
• MalfunctionApr 7, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETER WAS TOO STRONG AND EVEN AFTER REMOVING THEM, THERE WAS SOME ADHESIVE LEFT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11628758 ↗
• MalfunctionApr 2, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE DIFFICULT TO REMOVE AND THE PATIENT SAID THE 35302 WAS THE BEST, BUT IT WAS STILL VERY DIFFICULT TO REMOVE. PATIENT STATED THAT USING A SOAPY WATER DID NOT REALLY HELP WITH REMOVING THESE EXTERNALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11607223 ↗
• MalfunctionDec 26, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT STATED THEY CANNOT GET GLUE OFF FROM PENIS, WARM WATER & WASH CLOTH DOESN'T DO IT. REPRESENTATIVE ADVISED PATIENT TO WET THE RAG WITH HOT WATER AND WRAP AROUND PENIS FOR A BIT BEFORE REMOVING. THE HEAT AND WATER SHOULD HELP BREAK DOWN THE ADHESIVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11073806 ↗
• MalfunctionSep 2, 2020Nonstandard Device; Physical Resistance/Sticking; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER ADHESIVE WOULD NOT COME OFF, EVEN BY USING THE SOAP AND WATER.

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 10485301 ↗
• MalfunctionJul 24, 2020Nonstandard Device; Therapeutic or Diagnostic Output Failure; Nonstandard Device

  IT WAS REPORTED THAT THE GETTING OFF THE EXTERNAL CATHETER WAS A NIGHTMARE DUE TO STRONG ADHESION.

  Patient problems: Adhesion(s); No Consequences Or Impact To Patient

  MAUDE report 10321544 ↗
• MalfunctionMay 26, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN WHILE REMOVING THE EXTERNALS. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Pain

  MAUDE report 10089416 ↗
• MalfunctionMar 11, 2020Nonstandard Device; Difficult to Remove; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETER WAS VERY STRONG, WHICH CAUSED A DIFFICULT REMOVAL. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 9819274 ↗
• InjuryJan 27, 2020Device Contamination with Body Fluid; Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BLADDER INFECTION THAT CAUSED HIM TO SEE BLOOD IN THE MALE EXTERNAL CATHETER.

  Patient problems: Blood Loss; Patient Problem/Medical Problem; Unspecified Infection

  MAUDE report 9633423 ↗
• MalfunctionSep 4, 2019Product Quality Problem; Difficult to Remove; Product Quality Problem

  IT WAS REPORTED THAT THE ADHESIVE WAS TOO STRONG, CAUSING THE MECS TO BE DIFFICULT TO REMOVE.

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

  MAUDE report 8961879 ↗
• MalfunctionJul 31, 2019Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE SPIRIT STYLE 1 CATHETERS HAD TOO MUCH ADHESIVE. AS A RESULT THE PATIENT HAD TO HAVE A NURSE HELP TO REMOVE THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8846515 ↗
• MalfunctionMay 22, 2019Nonstandard Device; Nonstandard Device; Difficult to Remove; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETER WAS TOO STRONG ALLEGEDLY MAKING IT DIFFICULT TO REMOVE THE CATHETER. THE COMPLAINANT REPORTEDLY HAD TO USE A HOT WET TOWEL AND THE CATHETER CAME OFF AFTER ABOUT 30 MINUTES OF TRYING.

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

  MAUDE report 8631942 ↗
• MalfunctionFeb 11, 2019Nonstandard Device; Material Integrity Problem; Nonstandard Device

  IT WAS REPORTED THAT THE SPIRIT MALE EXTERNAL CATHETERS CONTAINED TOO MUCH ADHESIVE. THE PATIENT EXPERIENCED PAIN DURING REMOVAL OF THE CATHETERS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 8328484 ↗