BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IV PREP WIPES

    MDR report key: 2220807 · Received August 23, 2011

    Report

    Report Number
    3006760724-2011-00028
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    April 29, 2011
    Report Date
    August 22, 2011
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    NEC
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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". NO PRODUCT WAS RETURNED BY THE CUSTOMER AND NO LOT NUMBER WAS PROVIDED. CONTROL SAMPLES (FROM STOCK) OF ALL LOTS OF IV PREP WIPES PRODUCED AT THIS MANUFACTURING FACILITY 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 CONCLUDED THERE WAS NO CORRELATION BETWEEN THE REPORTED SYMPTOMS AND THE USE OF IV PREP WIPES. (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTS BACK IN (B)(6), 2011 SHE WAS HOSPITALIZED, AND WAS FOUND TO HAVE HIGH LEVELS OF BACTERIA IN HER BLOOD OF AN UNKNOWN SOURCE. PT REPORTS SHE MAY HAVE USED IV PREP WIPES FROM THE AFFECTED LOT NUMBERS DURING THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IV PREP WIPES BANDAGE, LIQUID, SKIN PROTECTANT NEC SMITH & NEPHEW WOUND MANAGEMENT 59421200 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization