PUREWICK MALE EXTERNAL CATHETER
Report
- Report Number
- 1018233-2025-00438
- Event Type
- Death
- Date Received
- January 30, 2025
- Date of Event
- November 21, 2024
- Report Date
- July 9, 2025
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- NZU
- UDI-DI
- 00801741226465
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS AVAILABLE FOR EVALUATION AND FURTHER INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS. NO ACTIONS CAN BE TAKEN AT THIS TIME SINCE A ROOT CAUSE WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: WARNINGS: DO NOT USE ON IRRITATED SKIN. EXAMPLES INCLUDE, BUT ARE NOT LIMITED TO, RASHES, SKIN TEARS, OR BLISTERS. DO NOT COVER FRESH SURGICAL WOUNDS WITH THE DEVICE. DO NOT USE THE DEVICE WITH ANY MATERIAL OR IN ANY POSITION THAT BLOCKS THE VENTS ON THE FRONT OF THE DEVICE OR DOES NOT ALLOW FOR AIRFLOW THROUGH THE DEVICE. EXAMPLES INCLUDE, BUT ARE NOT LIMITED TO, TIGHT CLOTHING OR BRIEFS. TO AVOID POTENTIAL SKIN INJURY, NEVER PULL THE DEVICE DIRECTLY AWAY FROM THE USER. ALWAYS PEEL IN THE DIRECTION FROM HEAD TO FOOT. STOP USE IF AN ALLERGIC REACTION OCCURS. AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. DISPOSE OF IN ACCORDANCE WITH APPLICABLE LOCAL, STATE, AND FEDERAL LAWS AND REGULATIONS. PRECAUTIONS: NOT RECOMMENDED FOR USERS WHO: ARE AGITATED, COMBATIVE, OR UNCOOPERATIVE AND MIGHT REMOVE THE DEVICE. HAVE FREQUENT EPISODES OF BOWEL INCONTINENCE WITHOUT A FECAL MANAGEMENT SYSTEM IN PLACE. HAVE SKIN IRRITATION OR BREAKDOWN AT THE SITE. DO NOT USE BARRIER CREAMS, LOTIONS, OR OINTMENTS ON THE PENIS OR PUBIC SKIN AROUND THE BASE OF THE PENIS WHEN USING THE DEVICE. THESE MAY IMPEDE SUCTION OR WEAKEN ADHESIVE. PROCEED WITH CAUTION IN USERS WHO HAVE HAD RECENT SURGERY OF THE EXTERNAL MALE ANATOMY. ALWAYS CHECK SKIN FOR IRRITATION OR BREAKDOWN AND CLEAN AND DRY THE SKIN PRIOR TO PLACEMENT OF A NEW DEVICE. CORRECTION: D. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
IT WAS REPORTED THAT PATIENT CONTRACTED A MALE YEAST INFECTION THAT WENT SEPTIC AFTER USING THE PUREWICK MALE EXTERNAL CATHETER. AT THE TIME PATIENT WAS MEDICALLY FRAGILE AND THEY DIED IN 2024 FROM LIVER AND KIDNEY FAILURE CAUSED PRIMARILY BY THE TOXIC ANTIFUNGALS GIVEN TO THEM TO TREAT THAT SEPTIC INFECTION. THE PRODUCT WAS SUPPOSED TO WICK AWAY URINE AND WAS SUPPOSED TO BE SUCTIONED INTO A VACUUM BOTTLE. CUSTOMER HAD A GREAT EXPERIENCE WITH THE FEMALE CATHETER AND HOPED THE MALE VERSION WOULD BE EVEN BETTER. INSTEAD, THE MALE VERSION KEPT URINE ON PATIENT SKIN OVERNIGHT AND THEY WERE AT THE EMERGENCY ROOM WITHIN 24 HRS WITH A URINARY TRACT INFECTION THAT TURNED SEPTIC. THE TESTS SHOWED CANDIDIASIS AS THE MAIN PROBLEM, AND PATIENT WAS SUBSEQUENTLY TREATED WITH STRONG ANTIFUNGAL MEDS THAT BASICALLY OVERWHELMED THEIR LIVER AND KIDNEYS. PATIENT DIED IN 2024 OF LIVER AND KIDNEY FAILURE. THIS MEDWATCH REPORT WAS RECEIVED VIA EMAIL ON 09-JAN-2025. BD HAS COMPLETED A REVIEW OF COMPLAINTS TO DETERMINE IF THIS ISSUE WAS PREVIOUSLY REPORTED; HOWEVER, THERE WERE NO COMPLAINTS IDENTIFIED RELATED TO THIS MEDWATCH REPORT. BD IS UNABLE TO OBTAIN ADDITIONAL INFORMATION AS THE INITIAL REPORTER HAS ASKED TO REMAIN CONFIDENTIAL.
IT WAS REPORTED THAT PATIENT CONTRACTED A MALE YEAST INFECTION THAT WENT SEPTIC AFTER USING THE PUREWICK MALE EXTERNAL CATHETER. AT THE TIME PATIENT WAS MEDICALLY FRAGILE AND THEY DIED IN 2024 FROM LIVER AND KIDNEY FAILURE CAUSED PRIMARILY BY THE TOXIC ANTIFUNGALS GIVEN TO THEM TO TREAT THAT SEPTIC INFECTION. THE PRODUCT WAS SUPPOSED TO WICK AWAY URINE AND WAS SUPPOSED TO BE SUCTIONED INTO A VACUUM BOTTLE. CUSTOMER HAD A GREAT EXPERIENCE WITH THE FEMALE CATHETER AND HOPED THE MALE VERSION WOULD BE EVEN BETTER. INSTEAD, THE MALE VERSION KEPT URINE ON PATIENT SKIN OVERNIGHT AND THEY WERE AT THE EMERGENCY ROOM WITHIN 24 HRS WITH A URINARY TRACT INFECTION THAT TURNED SEPTIC. THE TESTS SHOWED CANDIDIASIS AS THE MAIN PROBLEM, AND PATIENT WAS SUBSEQUENTLY TREATED WITH STRONG ANTIFUNGAL MEDS THAT BASICALLY OVERWHELMED THEIR LIVER AND KIDNEYS. PATIENT DIED IN 2024 OF LIVER AND KIDNEY FAILURE. THIS MEDWATCH REPORT WAS RECEIVED VIA EMAIL ON 09-JAN-2025. BD HAS COMPLETED A REVIEW OF COMPLAINTS TO DETERMINE IF THIS ISSUE WAS PREVIOUSLY REPORTED; HOWEVER, THERE WERE NO COMPLAINTS IDENTIFIED RELATED TO THIS MEDWATCH REPORT. BD IS UNABLE TO OBTAIN ADDITIONAL INFORMATION AS THE INITIAL REPORTER HAS ASKED TO REMAIN CONFIDENTIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 503946 | PUREWICK MALE EXTERNAL CATHETER | PUREWICK MALE EXTERNAL CATHETER | NZU | C.R. BARD, INC. (COVINGTON) -1018233 | NGJU0399 | 00801741226465 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male | Hospitalization| R| D |