BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNI-SOLVE WIPES

    MDR report key: 2182827 · Received July 28, 2011

    Report

    Report Number
    3006760724-2011-00011
    Event Type
    Death
    Date Received
    July 28, 2011
    Date of Event
    April 26, 2010
    Report Date
    July 27, 2011
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    KOX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    3006760724-04-06-2011-00
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT RETURN ANY PRODUCT. WE WERE UNABLE TO CONFIRM THE COMPLAINT SINCE THE LOT NUMBER WAS NOT PROVIDED AND NO SAMPLES WERE TESTED. S&N HAS MANUFACTURED THIS PRODUCT AT 2 DIFFERENT LOCATIONS AND SO WITHOUT THE LOT NUMBER, THE PRODUCTION RECORDS CANNOT BE REVIEWED AND FURTHER INVESTIGATION CANNOT BE PERFORMED. CONTROL SAMPLES (FROM RETAINS STOCK) OF SOME LOT OF UNI-SOLVE WIPES MANUFACTURED BY TRIAD WERE ANALYZED BY AN INDEPENDENT TEST LABORATORY AND MET FINISHED PRODUCT SPECIFICATIONS WITH NO EVIDENCE OF MICROBIAL CONTAMINATION FOUND. AN INDEPENDENT MEDICAL REVIEW OF THIS EVENT INDICATED THAT THERE IS NO MEDICAL EVIDENCE TO SUPPORT ANY RELATIONSHIP BETWEEN THE USE OF UNISOLVE WIPES, AND THE PATIENT'S SYMPTOMS AND/OR SUBSEQUENT DEATH.

    Additional Manufacturer Narrative · 1

    ACTIVE INVESTIGATION IS CURRENTLY IN PROGRESS BY SMITH & NEPHEW, AS WELL AS A REVIEW OF THE INCIDENT DETAILS BY OUR MEDICAL ADVISOR. INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENT REPORT ONCE A THOROUGH INVESTIGATION HAS BEEN COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THIS (B)(4) COMPLAINT WAS RECEIVED POST SMITH & NEPHEW'S REMEDIAL ACTION (VOLUNTARY RECALL) TO PREVENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM TO THE PUBLIC HEALTH ((B)(4)). ULCER THINGS APPEARED THEN WENT AWAY AFTER (B)(6) UNDER DOCTORS CARE. PATIENT PLACED ON BAG IN 1998, AND DEVELOPED URINARY TRACT INFECTION, AND SUBSEQUENTLY WENT SEPTIC. PATIENT DIED ON OR AROUND (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNI-SOLVE WIPES SOLVENT, ADHESIVE TAPE KOX SMITH & NEPHEW WOUND MANAGEMENT 402300

    Patients

    Seq Age Sex Outcome Treatment
    1 Death