Spirit® Hydrocolloid Adhesive Sheath 37303Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741071195), received between Aug 17, 2018 and May 31, 2023 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (17 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THESE MALE EXTERNAL CATHETERS WERE TOO STICKY AND VERY HARD TO GET OFF. PER FOLLOW UP VIA PHONE ON 05JUN2023, THE ADHESIVE WAS SO STRONG ON THE MALE EXTERNAL CATHETER THAT WHEN TRYING TO REMOVE THE FOLLOWING DAY, IT WOULD BE VERY DIFFICULT TO REMOVE. CUSTOMER STATED THAT SOMETIMES IT TOOK UP TO AN HOUR TO REMOVE ALL OF THE GLUE. ALSO STATED THAT IT ONLY HAPPENED WITH THE VERY LAST ORDER THEY RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17031899 ↗
• MalfunctionMay 4, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD ISSUES WITH FOUR MALE EXTERNAL CATHETER. THEY THAT HAD TOO MUCH ADHESIVE AND THE PATIENT COULD NOT GET THEM OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16868028 ↗
• MalfunctionMar 13, 2023Nonstandard Device; Nonstandard Device

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

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 16529292 ↗
• MalfunctionAug 25, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER HAD BEEN PULLING ON THE PATIENT FORESKIN. LIBERATOR REPRESENTATIVE SENT OUT DIFFERENT SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15293522 ↗
• MalfunctionAug 8, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD TROUBLE WITH A FEW OF THE MALE EXTERNAL CATHETERS AND THE ADHESIVE, CAUSED PAIN WHILE TAKING IT OFF. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 15182537 ↗
• MalfunctionFeb 9, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE NOT STAYING ON AS GOOD AND THE PATIENT NEED TO USE 2 CATHETERS A DAY. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS. AS PER ADDITIONAL INFORMATION RECEIVED VIA LIBERATOR ON (B)(6) 2022, STATED THAT THESE KINKS AND DID NOT STAY IN PLACE. PER ADDITIONAL INFORMATION RECEIVED VIA LIBERATOR ON (B)(6) 2022. STATED THAT THE PATIENT STARTED USING A DIFFERENT SIZE AND FIXED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13499399 ↗
• InjuryDec 10, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT GOT URINARY TRACT INFECTION FROM USING THE MALE EXTERNAL CATHETER AND IT SHOT THE PATIENT'S BLOOD SUGAR TO 500 AND THE PATIENT HAD TO BE HOSPITALIZED. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 12975265 ↗
• MalfunctionOct 18, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS HAD TOO MUCH ADHESION ON THEM. SO THE PATIENT PREFERRED THE ONES THAT THEY USED PREVIOUSLY (PCN# (B)(4)). IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR LESS THAN 90 DAYS. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021, CUSTOMER STATED THAT THE MALE EXTERNAL CATHETER STYLE 2 AND STYLE 3 WERE TOO STICKING AND TOO DIFFICULT TO REMOVE. PATIENT EXPERIENCED SOME DISCOMFORT IN THE REMOVAL OF CONDOM. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647427 ↗
• MalfunctionMay 21, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT DID NOT LIKE THE MALE EXTERNAL CATHETERS AND THE GLUE STAYED ON WHEN TRIED TO TAKE IT OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863056 ↗
• InjuryApr 1, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF USING MALE EXTERNAL CATHETERS THAT RESULTED IN URINARY TRACT INFECTION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 11603099 ↗
• MalfunctionFeb 25, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS HAD A GOOD GRIP WHICH MADE IT DIFFICULT TO REMOVE. IT WAS REPORTED THAT IT CAUSED SKIN LESIONS.

  Patient problems: Skin Tears

  MAUDE report 11378742 ↗
• MalfunctionFeb 25, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS HAD A GOOD GRIP WHICH MADE THE CATHETER DIFFICULT TO REMOVE AND CAUSED THE SKIN LESIONS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Localized Skin Lesion; Skin Tears

  MAUDE report 11378732 ↗
• MalfunctionFeb 8, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER STUCK ON TO THE PATIENT DUE TO TOO MUCH GLUE AND IT TORE THE SKIN A LITTLE WHILE REMOVING. PATIENT WAS NOW USING ADHESIVE REMOVER TO HELP FOR REMOVAL. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE SKIN TEARS.

  Patient problems: Skin Tears

  MAUDE report 11297817 ↗
• MalfunctionOct 16, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS DIFFICULT TO REMOVE DUE TO STRONG ADHESIVE.

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

  MAUDE report 10689328 ↗
• MalfunctionMay 21, 2020Nonstandard Device; Nonstandard Device; Product Quality Problem

  IT WAS REPORTED THAT THE MALE EXTERNALS WERE TEARING PATIENT'S SKIN AND CAUSED BLEEDING. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem; Skin Tears

  MAUDE report 10079687 ↗
• MalfunctionFeb 26, 2020Loss of or Failure to Bond; Leak/Splash; Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT SAID THE ADHESIVE HAD ¿GONE DOWN¿, WHICH CAUSED THE EXTERNALS TO COME OFF AT NIGHT. HE ALSO SAID THEY WOULD COME OFF IN THE SHOWER, CAUSE PAIN, MAKE HIS SKIN RED AND BLUE, AND LEAVE ADHESIVE ON HIS SKIN. PER FOLLOW UP WITH THE CUSTOMER ON 5FEB2020, THE ADHESIVE WAS STILL STUCK ON THE PATIENT AGAIN. IT WAS UNKNOWN IF HE RECEIVED MEDICAL INTERVENTION. HE TRIED THE 32303 SAMPLES AND LIKED THEM. PER FOLLOW UP WITH THE CUSTOMER ON 11FEB2020, THE CUSTOMER EXPERIENCED BLEEDING WHILE USING THIS MEC. IT WAS UNKNOWN IF HE RECEIVED MEDICAL INTERVENTION. PER FOLLOW UP WITH THE CUSTOMER ON 14FEB2020, THE EXTERNAL CATHETERS WERE LEAKING DUE TO A LACK OF ADHESIVE.

  Patient problems: Pain; Patient Problem/Medical Problem; Skin Discoloration

  MAUDE report 9759173 ↗
• MalfunctionFeb 24, 2020Loss of or Failure to Bond; Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT SAID THE ADHESIVE HAD ¿GONE DOWN¿ WHICH CAUSED THE EXTERNALS TO COME OFF AT NIGHT. HE ALSO SAID THEY CAME OFF IN THE SHOWER, CAUSED PAIN, MADE HIS SKIN RED AND BLUE, AND LEFT ADHESIVE ON HIS SKIN. PER FOLLOW UP WITH THE CUSTOMER ON 5FEB2020, THE ADHESIVE WAS STILL STUCK ON THE PATIENT AGAIN. IT WAS UNKNOWN IF HE RECEIVED MEDICAL INTERVENTION. HE TRIED THE 32303 SAMPLES AND LIKED THEM.

  Patient problems: No Consequences Or Impact To Patient; Pain; Skin Discoloration

  MAUDE report 9745370 ↗
• MalfunctionSep 23, 2019Nonstandard Device; Difficult to Remove; Nonstandard Device

  IT WAS REPORTED THAT SOME OF THE MEC'S ADHESIVE WAS TOO STRONG MAKING THEM DIFFICULT TO REMOVE. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 9104971 ↗
• MalfunctionJul 29, 2019Nonstandard Device; Nonstandard Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE SPIRIT STYLE 2 CATHETERS HAD TOO MUCH ADHESIVE AND AS A RESULT, THE CATHETERS WOULD NOT UNROLL PROPERLY. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8838823 ↗
• MalfunctionFeb 5, 2019Nonstandard Device; Difficult to Remove; Material Integrity Problem; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS DIFFICULT TO REMOVE DUE TO VERY STRONG ADHESIVE. THE PATIENT ADVISED THAT IT TOOK 15 MINUTES TO REMOVE THE CATHETER WITH WARM WATER. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 8307326 ↗
• MalfunctionAug 17, 2018Component Missing

  IT WAS REPORTED THAT THE TIP OF THE MALE EXTERNAL CATHETER WAS MISSING.

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

  MAUDE report 7794741 ↗