BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNI-SOLVE WIPES

    MDR report key: 2216608 · Received August 18, 2011

    Report

    Report Number
    3006760724-2011-00019
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    KOX
    PMA / PMN Number
    K973228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SENT PRODUCT SAMPLES. WE WERE UNABLE TO CONFIRM THE COMPLAINT. HENCE LABORATORY TESTING WAS PERFORMED ON SOME OF THE RETURNED SAMPLES OF THIS LOT, AND CONTROL SAMPLES (FROM STOCK) OF ADDITIONAL LOTS OF UNI-SOLVE WIPES WERE ANALYZED BY AN INDEPENDENT TEST LABORATORY AND MET FINISHED PRODUCT SPECIFICATIONS WITH NO EVIDENCE OF MICROBIAL CONTAMINATION FOUND. BATCH RECORDS FOR THE LOTS INDICATE ALL SPECIFICATIONS WERE MET AT THE TIME OF RELEASE AND NO INCONSISTENCIES WERE NOTED. AN INDEPENDENT MEDICAL REVIEW OF THIS COMPLAINT THIS PRODUCT HAS CONCLUDED THAT THERE WAS NO CORRELATION BETWEEN THE REPORTED SYMPTOMS AND THE USE OF THE S&N WIPES.

    Additional Manufacturer Narrative · 1

    ACTIVE INVESTIGATION IN PROGRESS; RESULTS OF INVESTIGATION WILL BE PROVIDED IN SUPPLEMENT REPORT. (B)(4).

    Description of Event or Problem · 1

    THIS UNISOLVED 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 STATES SHE WAS RELEASED FROM THE HOSPITAL (B)(6) 2011. PATIENT ADMITTED ON (B)(6) 2011. PATIENT STATES SHE NOTICED HER SKIN WAS BLACK AND BLUE. PATIENT CALLED HER PHYSICIAN AND WAS TOLD TO GO TO THE HOSPITAL. PATIENT STATES HER BLOOD PLATELETS WERE DOWN. PLATLET NUMBER 100. PATIENT STATES NORMAL PLATLET NUMBER SHOULD BE 40,000. PATIENT STATES SHE RECEIVED AN INFUSION DURING HER HOSPITAL STAY. EMERGENCY ROOM PHYSICIAN STATED PATIENT WAS DIAGNOSED AS HAVING A BACTERIAL INFECTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNI-SOLVE WIPES SOLVENT, ADHESIVE TAPE KOX SMITH & NEPHEW WOUND MANAGEMENT 402300 0H185

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization