BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKIN PREP WIPES

    MDR report key: 2251031 · Received September 16, 2011

    Report

    Report Number
    3006760724-2011-00047
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    May 31, 2011
    Report Date
    September 1, 2011
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    NEC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTIVE INVESTIGATION IN PROGRESS; RESULTS OF INVESTIGATION TO BE PROVIDED IN A SUPPLEMENT REPORT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT RETURN ANY PRODUCT. WE WERE UNABLE TO CONFIRM THE COMPLAINT. CONTROL SAMPLES (FROM STOCK) OF LOT 1A248 MANUFACTURED BY TRIAD WERE ANALYZED BY AN INDEPENDENT TEST LABORATORY AND MET FINISHED PRODUCT SPECIFICATIONS WITH NO MICROBIAL GROWTH. AN INDEPENDENT MEDICAL REVIEW CONCLUDED THERE WAS NO CORRELATION BETWEEN THE REPORTED SYMPTOMS AND THE USE OF SKIN PREP WIPES. BATCH RECORDS FOR THE LOT INDICATE ALL SPECIFICATIONS WERE MET AT THE TIME OF RELEASE AND NO INCONSISTENCIES WERE NOTED.

    Description of Event or Problem · 1

    THIS SKIN PREP COMPLAINT WAS RECEIVED POST SMITH & NEPHEW'S REMEDIAL ACTION (VOLUNTARY RECALL) TO PREVENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM TO THE PUBLIC HEALTH (REF. RECALL #3006760724-04-06-2011-001R). PATIENT HAS BEEN IN THE HOSPITAL FOR 3 WEEKS WITH AN ENCEPHALITIS INFECTION AT THE OSTOMY, WHICH THEY FEEL MAY BE RELATED TO THE WIPES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKIN PREP WIPES BANDAGE, LIQUID, SKIN PROTECTANT NEC SMITH & NEPHEW WOUND MANAGEMENT 420400 1A248

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization