BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IV PREP WIPES

    MDR report key: 2302429 · Received October 20, 2011

    Report

    Report Number
    3006760724-2011-00055
    Event Type
    Injury
    Date Received
    October 20, 2011
    Date of Event
    August 10, 2011
    Report Date
    October 17, 2011
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    NEC
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    3006760724-04-06-2011-00
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW WAS CONTACTED REGARDING THE ABOVE DESCRIBED INCIDENT, WHICH WAS REPORTED AS A FIELD COMPLAINT FOR "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.

    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). A CUSTOMER WHO USED THE RECALLED IV PREP WIPES REPORTED SHE HAD A "STRONG ALLERGIC REACTION TO THE PRODUCT WHICH CREATED A LARGE DEGREE OF DISCOMFORT AND REQUIRED REPEATED MEDICAL TREATMENT."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other