Spirit® Hydrocolloid Adhesive Sheath 39303Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00801741071348), received between Dec 11, 2017 and Dec 21, 2022 — classified as 4 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (29 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT EXPRESSED CONCERN WITH REMOVING OF THE MALE EXTERNAL CATHETER IN THE MORNINGS. PATIENT SUGGESTED ADHESIVE REMOVER WIPES. AS PER CLARIFICATION MAIL RECEIVED ON 07DEC2022, THE PATIENT HAD BEEN USING SOAP TO TRY AND REMOVE THE ADHESIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16025468 ↗
• MalfunctionDec 9, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THESE MALE EXTERNAL CATHETERS WERE DIFFICULT TO TAKE OFF. PATIENT HAD TO USE VASELINE WHEN REMOVING THE CATHETERS AND THAT WORKED. HOWEVER, THE PATIENT WANTED THIS NOTATED FOR FUTURE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949655 ↗
• MalfunctionAug 30, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS TOUGH TO REMOVE AND CAUSED IRRITATION ONCE REMOVED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 15319438 ↗
• MalfunctionMay 6, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT INFORMED THAT TWO OF THE MALE EXTERNAL CATHETERS IN THEIR ORDER WERE DEFECTIVE AND STUCK TOGETHER. THE PATIENT WAS NOT ABLE TO USE THEM AT ALL. THE ADHESIVE WAS STUCK TOGETHER AS THE DRAINAGE HOLE WAS TOO SMALL. BECAUSE THE URINE STARTED BACKING UP INTO THE CATHETER AND ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14306391 ↗
• MalfunctionMay 2, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER KEPT CLOGGING UP BECAUSE THE SIDES WOULD GET STUCK TO EACH OTHER, MIGHT BE TOO MUCH ADHESION. REPRESENTATIVE STATED THAT THEY COULD SEND THE SAMPLES OF OTHER CONDOM CATHETERS THAT HAVE LESS ADHESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14257623 ↗
• MalfunctionDec 2, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE TOO STICKY, HARD TO PULL OFF AND THEY HURT THE PATIENT. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR LESS THAN 90 DAYS. NO MEDICAL INTERVENTION WAS REPORTED. PER ADDITIONAL INFORMATION FROM CARDINAL HEALTH, IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE STICKY AND HARD TO GET OFF.

  Patient problems: Pain

  MAUDE report 12918963 ↗
• MalfunctionNov 22, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER BATCH WAS STICKY AND DID NOT STAY ON WELL. THE PATIENT HAS BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12853384 ↗
• MalfunctionOct 20, 2021Nonstandard Device; Nonstandard Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12666005 ↗
• MalfunctionOct 15, 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. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR LESS THAN 90 DAYS. PER ADDITIONAL INFORMATION RECEIVED ON 03NOV2021, 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 12639731 ↗
• MalfunctionOct 13, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE TOO STICKY. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT MORE THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624580 ↗
• MalfunctionJul 25, 2021Missing Information; Missing Information

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS DID NOT COME WITH REMOVAL INSTRUCTIONS. THE PATIENT STATED THAT THE CATHETER DID NOT STAY ON AND WHEN THE PATIENT USED THE CATHETER FOR THE FIRST TIME THE ADHESIVE GOT OVER EVERYWHERE AND ALL OVER THE HANDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222978 ↗
• MalfunctionJul 23, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS DID NOT COME WITH REMOVAL INSTRUCTIONS. THE PATIENT STATED THAT THE CATHETER DID NOT STAY ON AND THE FIRST TIME THE PATIENT USED IT THE ADHESIVE GOT ¿EVERYWHERE¿ AND ALL OVER THE HANDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12218281 ↗
• MalfunctionJun 11, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER ADHESIVE WAS STICKING TO PATIENT WHICH CAUSING THE URINE NOT TO FLOW IN BACK AND MADE A MESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11985672 ↗
• MalfunctionJun 1, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT USING MALE EXTERNAL CATHETER HAD 3 OCCASIONS WHERE THE CATHETER HAD COME OFF AT NIGHT. PATIENT NOTICED THAT CATHETER DID NOT COME ALL THE WAY UP THE PENIS SHAFT AS THEY USED TO AND ALSO STATED THAT THE CATHETERS WERE USUALLY MORE DIFFICULT TO REMOVE. PATIENT WAS NOT SURE IF CATHETERS WERE COMING OFF BECAUSE THEY DID NOT HAVE ENOUGH ADHESIVE OR IF THEY WERE NOT LONG ENOUGH AND DID COMPLIMENT THAT THE SAFETY CAP THAT KEEPS THEM CLEAN. IT WAS ALSO REPORTED THAT THE MALE EXTERNAL CATHETERS HAD NOT GOOD ADHESIVE FOR LOT #JUEX2025 AND FOR LOT #JUEZ0288 AND THE CATHETERS WERE SHORTER THAN USUAL LOT#JUEZ0288. ALSO, CUSTOMER WANTED TO KNOW IF THERE HAD BEEN A CHANGE IN THE PRODUCT. PER CUSTOMER VIA PHONE ON 19MAY2021, CUSTOMER STATED THAT THE MALE EXTERNAL CATHETER WAS TOO BIG ( LOT # JUEY1009), HAD WEAK ADHESIVE (LOT # JUEY1009) THAT CAUSED ROLLED RIGHT OFF AND HALF WERE FOUND TO BE SHORTER (LOT # JUEY1009).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913937 ↗
• MalfunctionApr 9, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE CATHETER COLLAPSED ON ITSELF WHILE MOVING AROUND AT NIGHT. THE LIBERATOR REPRESENTATIVE STATED THAT SOME SUCTION WAS DEVELOPED. PER CUSTOMER VIA PHONE ON (B)(6) 2021 THE PATIENT EXPERIENCED SORE AND IRRITATION ON THE PENIS DURING THE CATHETER REMOVAL. THE CUSTOMER NOTED THAT THE ADHESIVE WAS TOO STRONG AND HAD TO USE A WARM WASH CLOTH TO SOFTEN THE GLUE AND REMOVE THE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER STATED THAT THE PATIENT HAS SENSITIVE SKIN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Irritability; Pressure Sore/Ulcer; Skin Inflammation/ Irritation

  MAUDE report 11643977 ↗
• MalfunctionApr 2, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE SAMPLES OF THE MALE EXTERNAL CATHETERS WITH ADHESIVE WERE 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 11607440 ↗
• InjuryApr 1, 2021Biocompatibility; Biocompatibility

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

  Patient problems: Urinary Tract Infection

  MAUDE report 11603104 ↗
• MalfunctionMar 25, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT STATED THAT THERE WAS TOO MUCH ADHESIVE NEAR THE TIP AND THE INSIDE OF THE MALE EXTERNAL CATHETER WHICH WAS STICKING TOGETHER AND NOT DRAINING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11569217 ↗
• MalfunctionMar 23, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE MORE DIFFICULT TO REMOVE, CAUSING PAIN TO THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 11556450 ↗
• MalfunctionMar 8, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THERE WAS TOO MUCH ADHESIVE WITH THE MALE EXTERNAL CATHETER WHICH CAUSED THE PATIENT TO EXPERIENCE THE SKIN IRRITATION AND REDNESS.

  Patient problems: Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 11436486 ↗
• MalfunctionMar 4, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN IRRITATION FROM THE MALE EXTERNAL CATHETERS. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP ON 09FEB2021, THE GLUE DID NOT STICK ON THE MALE EXTERNAL CATHETER, AND THE CATHETER WOULD FALL IMMEDIATELY DURING USE EVEN THOUGH IT WAS THE CORRECT SIZE. THE CUSTOMER NOTED THE AREA WAS CLEANED AND DRIED PRIOR TO APPLYING AND NO LOTIONS OR CREAMS WERE ADDED. THE CUSTOMER THEN SWITCHED TO USING ITEM 39303 AND NOTED THE CATHETER HAD STRONG ADHESIVE AND SO WAS STICKING TO THE PATIENT TOO HARD WHICH CAUSED IRRITATION. THE CUSTOMER REPORTEDLY USED A WARM WASH CLOTH TO ASSIST IN REMOVING THE CATHETER. OVER-THE-COUNTER CALMOSEPTINE CREAM WAS USED ON THE REACTION. THE CUSTOMER SWITCHED TO USING THE NATURAL MALE EXTERNAL CATHETER AND IT ALSO SEEMED TO BE CAUSING SOME IRRITATION TO THE PATIENT. PATIENT USES OTC CALMOSEPTINE CREAM FOR THE IRRITATION. THE CUSTOMER SUGGESTS THAT A PAD SHOULD BE MADE OVER THE ROUGH PORTION OF THE VELCRO STRAP OF THE MALE EXTERNAL CATHETER BECAUSE IT WAS NOT SMOOTH ON THE PATIENT¿S SKIN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 11412084 ↗
• InjuryOct 22, 2020Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE DOCTOR ADVISED PATIENT NOT TO USE THE MALE EXTERNAL CATHETERS. ALSO STATED THAT PATIENT GOT AN INFECTION FROM USING IT. STATED THAT IT WAS NOT A URINARY TRACT INFECTION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10718373 ↗
• MalfunctionOct 2, 2020Nonstandard Device; Physical Resistance/Sticking; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER HAD TOO MUCH ADHESIVE AND HENCE IT WAS STICKING TO ITSELF, BUT THE PATIENT GOT IT TO WORK.

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

  MAUDE report 10619510 ↗
• MalfunctionSep 17, 2020Nonstandard Device; Physical Resistance/Sticking; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS TOO STICKY. TOO MUCH GLUE MADE IT DIFFICULT TO APPLICATE THE CATHETER AND ALSO TO URINATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Consequences Or Impact To Patient

  MAUDE report 10546830 ↗
• MalfunctionAug 26, 2020Nonstandard Device; Physical Resistance/Sticking; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER SHEATH ADHESIVE WAS HARD TO REMOVE.

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

  MAUDE report 10456828 ↗