BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNISOLVE WIPES

    MDR report key: 2220119 · Received August 23, 2011

    Report

    Report Number
    3006760724-2011-00026
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    April 28, 2011
    Report Date
    August 22, 2011
    Manufacturer
    WOUND US MANUFACTURING SITE
    Product Code
    KOX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW WAS CONTACTED REGARDING THE ABOVE DESCRIBED INCIDENT, WHICH WAS REPORTED AS A FIELD COMPLAINT FOR INFECTION-GENERAL/SYSTEMIC. THE CUSTOMER SENT IN SOME PRODUCT SAMPLES. WE WERE UNABLE TO CONFIRM THE COMPLAINT BASED ON INSPECTION OF THE RETURNED SAMPLES, HENCE LABORATORY TESTING WAS PERFORMED. BOTH THE RETURNED SAMPLE(S) OF LOT 0K209 AND CONTROL SAMPLES OF ADDITIONAL LOTS (FROM STOCK) 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 LOT INDICATE ALL SPECIFICATIONS WERE MET AT THE TIME OF RELEASE AND NO INCONSISTENCIES WERE NOTED. AN INDEPENDENT MEDICAL REVIEW CONCLUDED THERE WAS NO CORRELATION BETWEEN THE REPORTED SYMPTOMS AND THE USE OF UNI-SOLVE WIPES. (B)(4)

    Description of Event or Problem · 1

    ADVERSE INCIDENT MR. (B)(6) WAS HOSPITALIZED (B)(6), 2011 FOR A U.T.I AND HE WAS GIVEN ANTIBIOTICS INTRAVENOUSLY FOR 5 DAYS AND RELEASED AND PRESCRIBED ANTIBIOTICS TO TAKE TILL THEY WERE GONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNISOLVE WIPES SOLVENT, ADHESIVE TAPE KOX WOUND US MANUFACTURING SITE GB402300 0K209

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization