BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUREWICK FEMALE EXTERNAL CATHETER

    MDR report key: 14347059 · Received May 10, 2022

    Report

    Report Number
    1018233-2022-03550
    Event Type
    Death
    Date Received
    May 10, 2022
    Date of Event
    January 27, 2022
    Report Date
    August 31, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NZU
    UDI-DI
    00801741189050
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE. SAMPLE WAS NOT RETURNED FOR EVALUATION. SOME OF THE POTENTIAL CAUSES IDENTIFIED ARE: USER FORGETS OR IS UNAWARE OF NEED TO EVALUATE SKIN SITE EVERY 2 HOURS AND STOPS USAGE OF DEVICE IF PATIENT IS EXPERIENCING SKIN IRRITATION OR BREAKDOWN AT THE SITE OR DEVICE IS SOILED WITH FECES OR BLOOD. HOWEVER DUE TO THE LIMITED INFORMATION AVAILABLE, THERE IS NO EVIDENCE TO CONFIRM OR DISCARD ANY OF THESE CAUSES AS THE DEFINITIVE CAUSE OF THE EVENT. IT WAS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "WARNINGS: TO AVOID POTENTIAL SKIN INJURY, NEVER PUSH OR PULL THE PUREWICKTM FEMALE EXTERNAL CATHETER AGAINST THE SKIN DURING PLACEMENT OR REMOVAL. DISCONTINUE USE IF AN ALLERGIC REACTION OCCURS. PRECAUTIONS: NOT RECOMMENDED FOR PATIENTS WHO ARE: HAVING FREQUENT EPISODES OF BOWEL INCONTINENCE WITHOUT A FECAL MANAGEMENT SYSTEM IN PLACE EXPERIENCING SKIN IRRITATION OR BREAKDOWN AT THE SITE. PROCEED WITH CAUTION IN PATIENTS WHO HAVE UNDERGONE RECENT SURGERY OF THE EXTERNAL UROGENITAL TRACT. ALWAYS ASSESS SKIN FOR COMPROMISE AND PERFORM PERINEAL CARE PRIOR TO PLACEMENT OF A NEW PUREWICKTM FEMALE EXTERNAL CATHETER. RECOMMENDATIONS: PERFORM EACH STEP WITH CLEAN TECHNIQUE. IN THE HOME SETTING, WASH HANDS THOROUGHLY BEFORE DEVICE PLACEMENT. ASSESS DEVICE PLACEMENT AND PATIENT¿S SKIN AT LEAST EVERY 2 HOURS. REPLACE THE PUREWICKTM FEMALE EXTERNAL CATHETER EVERY 8-12 HOURS OR WHEN SOILED WITH FECES OR BLOOD. PER LABELING REVIEW, PUREWICK FEMALE CATHETER IS NOT RECOMMENDED FOR PATIENTS WHO HAVE FREQUENT EPISODES OF BOWER INCONTINENCE WITHOUT A FECAL MANAGEMENT SYSTEM IN PLACE. PER THE INFORMATION PROVIDED IN THIS EVENT, THE PATIENT WAS BOWEL INCONTINENT, HOWEVER IT IS UNKNOWN IF A FECAL MANAGEMENT SYSTEM WAS IN PLACE.¿ H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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 BARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A SORE IN THE PUBIC AREA WHILE USING THE PUREWICK FEMALE EXTERNAL CATHETER. NO MEDICAL INTERVENTION WAS REPORTED. IT WAS NOTED THAT THE PATIENT HAD BEEN USING PUREWICK PRODUCTS FOR MORE THAN 90 DAYS. PER FOLLOW UP VIA PHONE ON 06 APR 2022, A FAMILY MEMBER REPORTED THE PATIENT HAD PASSED AWAY. THE PATIENT DEVELOPED A RASH/SORE IN THE PUBIC AREA OF HER VAGINA WHICH SPREAD TO HER BUTTOCKS. PER CLINICAL FOLLOW UP VIA PHONE ON 07 APR 2022, THE PATIENT¿S HUSBAND STATED THE PATIENT HAD POOR MOBILITY, WAS INCONTINENT OF BLADDER AND BOWEL, AND SHE HAD BEEN IN HOSPICE CARE. HE STATED THE PUREWICK DEVICE WAS WORKING, AND HE VERIFIED THAT THE WICKS WERE CHANGED AT LEAST TWICE A DAY. THREE MONTHS PRIOR TO HER DEATH, THE PATIENT WENT TO THE HOSPITAL FOR TREATMENT OF THE WOUND. SHE WAS DIAGNOSED WITH A BONE INFECTION AND TREATED WITH ANTIBIOTICS. AN INDWELLING FOLEY CATHETER WAS INSERTED, AND IT REMAINED IN PLACE AFTER SHE WAS DISCHARGED HOME. HOSPICE NURSES WERE PERFORMING DRESSING CHANGES EVERY OTHER DAY, BUT THE WOUND DID NOT HEAL. THE (B)(6) PATIENT PASSED AWAY ON (B)(6) 2022, BUT THE HUSBAND DID NOT KNOW THE EXACT CAUSE OF DEATH SINCE HE DID NOT HAVE THE DEATH CERTIFICATE. PER CLINICAL FOLLOW UP VIA PHONE ON 13 APR 2022, THE PATIENT¿S HUSBAND REPORTED HE STILL DID NOT HAVE THE PATIENT¿S DEATH CERTIFICATE AND WAS UNSURE WHEN HE WOULD RECEIVE IT. HE STATED THE PATIENT¿S HEALTH WAS IN FAIR CONDITION UNTIL SHE DEVELOPED THE BONE INFECTION FROM THE WOUND. THE HUSBAND THINKS THE WOUND WAS CAUSED BY THE PUREWICK DEVICE, WHICH HE ALSO BELIEVED CONTRIBUTED TO HER DEATH. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A SORE IN THE PUBIC AREA WHILE USING THE PUREWICK FEMALE EXTERNAL CATHETER. NO MEDICAL INTERVENTION WAS REPORTED. IT WAS NOTED THAT THE PATIENT HAD BEEN USING PUREWICK PRODUCTS FOR MORE THAN 90 DAYS. PER FOLLOW UP VIA PHONE ON 06APR2022, A FAMILY MEMBER REPORTED THE PATIENT HAD PASSED AWAY. THE PATIENT DEVELOPED A RASH/SORE IN THE PUBIC AREA OF HER VAGINA WHICH SPREAD TO HER BUTTOCKS. PER CLINICAL FOLLOW UP VIA PHONE ON 07APR2022, THE PATIENT¿S HUSBAND STATED THE PATIENT HAD POOR MOBILITY, WAS INCONTINENT OF BLADDER AND BOWEL, AND SHE HAD BEEN IN HOSPICE CARE. HE STATED THE PUREWICK DEVICE WAS WORKING, AND HE VERIFIED THAT THE WICKS WERE CHANGED AT LEAST TWICE A DAY. THREE MONTHS PRIOR TO HER DEATH, THE PATIENT WENT TO THE HOSPITAL FOR TREATMENT OF THE WOUND. SHE WAS DIAGNOSED WITH A BONE INFECTION AND TREATED WITH ANTIBIOTICS. AN INDWELLING FOLEY CATHETER WAS INSERTED, AND IT REMAINED IN PLACE AFTER SHE WAS DISCHARGED HOME. HOSPICE NURSES WERE PERFORMING DRESSING CHANGES EVERY OTHER DAY, BUT THE WOUND DID NOT HEAL. THE 78-YEAR-OLD PATIENT PASSED AWAY ON (B)(6) 2022, BUT THE HUSBAND DID NOT KNOW THE EXACT CAUSE OF DEATH SINCE HE DID NOT HAVE THE DEATH CERTIFICATE. PER CLINICAL FOLLOW UP VIA PHONE ON 13APR2022, THE PATIENT¿S HUSBAND REPORTED HE STILL DID NOT HAVE THE PATIENT¿S DEATH CERTIFICATE AND WAS UNSURE WHEN HE WOULD RECEIVE IT. HE STATED THE PATIENT¿S HEALTH WAS IN FAIR CONDITION UNTIL SHE DEVELOPED THE BONE INFECTION FROM THE WOUND. THE HUSBAND THINKS THE WOUND WAS CAUSED BY THE PUREWICK DEVICE, WHICH HE ALSO BELIEVED CONTRIBUTED TO HER DEATH. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234164 PUREWICK FEMALE EXTERNAL CATHETER PUREWICK FEMALE EXTERNAL CATHETER NZU C.R. BARD, INC. (COVINGTON) -1018233 PWFX30 UNK 00801741189050

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Death