BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IV PREP WIPES

    MDR report key: 2220805 · Received August 23, 2011

    Report

    Report Number
    3006760724-2011-00029
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    April 29, 2011
    Report Date
    August 23, 2011
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    NEC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    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" AND "SKIN IRRITATION/REACTION". 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

    THIS IV 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 #3006760724-030211-001R). BLOOD INFECTION LEADING TO HOSPITALIZATION. PATIENT REPORTS THAT ONE DAY IN EARLY DECEMBER HE FELT SICK AND HAD ELEVATED TEMPERATURE WHICH CAUSED HIM TO GO TO THE HOSPITAL. PATIENT WAS ADMITTED AND STAYED FOR FOUR DAYS AND WAS TREATED WITH AROUND THE CLOCK IV ANTIBIOTIC'S. PATIENT CANNOT RECALL THE NAME OF THE ANTIBIOTIC.

    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