Spirit® Hydrocolloid Adhesive Sheath 39304Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00801741071355), received between Mar 6, 2018 and Oct 6, 2022 — classified as 5 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (21 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER DID NOT WORK FOR THE PATIENT. THEY WERE WIDE BANDS BUT PATIENT WAS SENT A SUB SAME PRODUCT BUT DIFF COM. THEY CLOSED UP AT NIGHT DUE TO MUCH GLUE PATIENT GOT RETRACTION AT NIGHT AND LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15550970 ↗
• MalfunctionSep 14, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WAS HAVING ISSUES WITH MALE EXTERNAL CATHETER THAT THERE WAS TOO MUCH ADHESIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15420221 ↗
• MalfunctionAug 16, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER HAD BEEN PULLING ON THEIR SKIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15234625 ↗
• MalfunctionNov 9, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON THE MALE EXTERNAL CATHETER WAS TOO STICKY, AND THEY WERE NOT WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12781007 ↗
• MalfunctionOct 11, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS HAD TOO MUCH ADHESIVE. PER ADDITIONAL INFORMATION RECEIVED VIA FOLLOW-UP ON (B)(6) 2022, IT WAS STATED THAT THE PATIENT WAS NOT HAVING ANY ISSUES WITH THE MALE EXTERNAL CATHETERS AND DID NOT REMEMBER MAKING A COMPLAINT IN REGARDS TO THEM AT ALL. CUSTOMER WAS VERY HAPPY WITH THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605795 ↗
• MalfunctionApr 8, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED BY THE PATIENT THAT SOMETIMES THE URINE BACKED UP IN THE CONDOM CATHETER AND IT WAS LEAKED. IT WAS STATED SOME OF THEM HAD SO MUCH GLUE. IT WAS NOTED THAT WHEN THE PATIENT TOOK IT OFF EXPERIENCED A SCRAP OF IT. THE REPRESENTATIVE ADVISED LOOKING INTO BOTH THE ISSUES AND THE PATIENT SWITCHED TO A NATURAL CONDOM CATHETER WITH NO GLUE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Rash

  MAUDE report 11636547 ↗
• MalfunctionMar 2, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER HAD TOO MUCH ADHESIVE. ALSO STATED THEY FIGURED IT OUT OVER TIME AND IT WORKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11402473 ↗
• MalfunctionFeb 15, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT MALE EXTERNAL CATHETER STUCK TO PATIENT'S PENIS AND IT TURNED ALL PURPLE. REPRESENTATIVE ADVISED PATIENT MIGHT NEED LARGER SIZE.

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

  MAUDE report 11326669 ↗
• MalfunctionNov 24, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS HAD TOO MUCH GLUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10891575 ↗
• MalfunctionNov 20, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS DIFFICULT TO REMOVE AND WERE IRRITATING PATIENTS SKIN, IT WAS FAILING 2-3 TIMES PER NIGHT. PER FOLLOW UP VIA PHONE ON 03NOV2020, THE STYLE 3 CATHETER WAS FOUND DIFFICULT TO REMOVE AND CAUSING SKIN IRRITATION. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Irritation

  MAUDE report 10877296 ↗
• MalfunctionOct 20, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE VERY STICKY AND PATIENT HAD HARD TIME REMOVING. LIBERATOR REPRESENTATIVE PROVIDED ADDITIONAL REMOVAL INSTRUCTIONS TO WRAP A WARM WASHCLOTH AROUND THE EXTERNAL TO HELP LOOSEN THE ADHESIVE. PER FOLLOW UP VIA LIBERATOR ON 01OCT20 THE PATIENT HAD IRRITATION NOW AND WAS NOT SURE WHAT TO DO TO RESOLVED THE ISSUE. REPRESENTATIVE ADVISED ABOUT SPEAKING WITH THE DOCTOR. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Irritation

  MAUDE report 10703584 ↗
• InjurySep 15, 2020Patient-Device Incompatibility; Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS STARTED TO BREAK PATIENT'S SKIN DOWN AND CAUSED URINARY TRACT INFECTION. MEDICAL INTERVENTION PROVIDED WAS UNKNOWN.

  Patient problems: Skin Irritation; Tissue Breakdown; Urinary Tract Infection

  MAUDE report 10536522 ↗
• InjurySep 1, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED URINARY TRACT INFECTION AND TREATED BY THE UROLOGIST AND WHILE THERE WAS NO ALLEGATION AGAINST ANY PRODUCT. IT WAS UNKNOWN WHETHER THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION, HISTORICALLY PROVIDED THE PATIENT WITH THE 802414 AND 39304. PER ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT ON (B)(6) 2020 VIA PHONE, THE PATIENT HAS EXPERIENCED MULTIPLE URINARY TRACT INFECTIONS AND RECEIVED THE TREATMENT WITH THE ANTIBIOTIC THERAPY AS PER THE UROLOGIST.

  Patient problems: Urinary Tract Infection

  MAUDE report 10479578 ↗
• MalfunctionJul 30, 2020Nonstandard Device; Therapeutic or Diagnostic Output Failure; Nonstandard Device

  IT WAS REPORTED THAT MALE EXTERNAL CATHETER DID NOT CAME OFF WELL. IT WAS ALSO STATED THAT PATIENT ENCOUNTERED THIS PROBLEM FOR THE FIRST TIME.

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

  MAUDE report 10345946 ↗
• MalfunctionJun 14, 2020Nonstandard Device; Nonstandard Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ADHESION OF THE MALE EXTERNAL CATHETER PULLED ON THE HAIR AND PATIENT COULD NOT SHAVE.

  Patient problems: Discomfort

  MAUDE report 10151541 ↗
• InjuryMay 27, 2020Biocompatibility; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A URINARY TRACT INFECTION AND ALSO EXPERIENCED PAIN OR PRESSURE WHILE URINATING. IT WAS UNKNOWN WHETHER MEDICAL INTERVENTION WAS PROVIDED FOR THE URINARY TRACT INFECTION.

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 10093037 ↗
• MalfunctionApr 4, 2020Nonstandard Device; Detachment of Device or Device Component; Nonstandard Device

  IT WAS REPORTED THAT PATIENT SAID THIS MALE EXTERNAL CATHETER WAS TEARING OFF HIS SKIN. NO MEDICAL INTERVENTION REPORTED.

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

  MAUDE report 9925872 ↗
• MalfunctionMar 9, 2020Nonstandard Device; Manufacturing, Packaging or Shipping Problem; Nonstandard Device

  IT WAS REPORTED THAT THE SOME OF THE MALE EXTERNALS HAD TOO MUCH ADHESIVE ON THEM. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 9805896 ↗
• MalfunctionMar 5, 2020Nonstandard Device; Difficult to Remove; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS HARD TO REMOVE AND ALLEGEDLY CAUSED THE PATIENT TO EXPERIENCE IRRITATION. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Irritation

  MAUDE report 9795155 ↗
• InjuryJun 28, 2019Inaccurate Flow Rate; Inaccurate Flow Rate; Infusion or Flow Problem

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS DID NOT DRAIN PROPERLY AND CAUSED URINE TO BACK UP. IT WAS REPORTED THAT THIS CAUSED THE PATIENT'S URINARY TRACT INFECTION THAT DID NOT GO AWAY AND CAUSED THE PATIENT TO BE HOSPITALIZED.

  Patient problems: Urinary Tract Infection

  MAUDE report 8745420 ↗
• InjuryJun 20, 2019Material Rupture; Material Twisted/Bent

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER GOT TWISTED WHICH ALLEGEDLY TRAPPED THE URINE AND CAUSED THE CATHETER TO "BLOW UP" AND "EXPLODE EVERYWHERE". THE PATIENT REPORTEDLY ENDED UP IN THE HOSPITAL WITH A URINARY TRACT INFECTION AFTER THE EVENT.

  Patient problems: Urinary Tract Infection

  MAUDE report 8716834 ↗
• MalfunctionDec 28, 2018Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT THE HOSPITAL ORDERED MEC PRODUCT CATALOG NUMBER 39304 BUT WHEN THE PACKAGE RECEIVED WAS OPENED, MEC PRODUCT CATALOG NUMBER 39302 WAS CONTAINED WITHIN THE PACKAGE.

  Patient problems: No Patient Involvement

  MAUDE report 8203838 ↗
• MalfunctionAug 17, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT DEVELOPED BLISTERS WHILE USING THE CATHETER. PER FOLLOW UP WITH THE COMPLAINANT BY PHONE, ON (B)(6) 2018 THE BLISTERS DID NOT REQUIRE ANY MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient; Pressure Sore/Ulcer

  MAUDE report 7794746 ↗
• MalfunctionAug 6, 2018Nonstandard Device; Difficult to Remove; Nonstandard Device

  IT WAS REPORTED THAT IT WAS DIFFICULT TO REMOVE THE CATHETER FROM THE PATIENT, THEREFORE IT WAS CUT OFF. A LIQUID ADHESIVE WAS REPORTEDLY APPLIED TO THE PATIENT'S PENIS BEFORE APPLICATION.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7752631 ↗
• MalfunctionJul 30, 2018Nonstandard Device; Appropriate Device Problem Term/Code Not Available; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE OF THE CATHETER WAS TOO STRONG.

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

  MAUDE report 7733313 ↗