BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IV PREP WIPES

    MDR report key: 2216606 · Received August 18, 2011

    Report

    Report Number
    3006760724-2011-00018
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 27, 2011
    Report Date
    December 12, 2011
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    NEC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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) AND CONTROL SAMPLES (FROM STOCK) OF LOT 0K193 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 IV PREP WIPES.

    Additional Manufacturer Narrative · 1

    ACTIVE INVESTIGATION IN PROGRESS; INVESTIGATION RESULTS TO BE PROVIDED IN A SUPPLEMENT REPORT. (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). PATIENT'S KIDNEY SHUT DOWN, AND SHE WAS ADMITTED AS INPATIENT ON (B)(6), 2011. EMERGENCY PHYSICIAN PRESCRIBED AN ANTIBIOTIC TO WHICH THE PATIENT EXPERIENCED AN ALLERGIC REACTION. PATIENT ALSO NOTICED REDNESS ON HER SIDE, AND STATES SHE HAD A REACTION TO SKIN PREP WIPES WHICH CAUSED BRONCHITIS.

    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 0K193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization