BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKIN PREP WIPES

    MDR report key: 2177751 · Received July 26, 2011

    Report

    Report Number
    3006760724-2011-00007
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    April 15, 2011
    Report Date
    July 20, 2011
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    KMF
    Removal / Correction Number
    3006760724-030211-001R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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-SITE/LOCAL". NO PRODUCT WAS RETURNED BY THE CUSTOMER. CONTROL SAMPLES (FROM STOCK) OF THE REPORTED LOTS 9K141 AND 0M180, 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. MEDICAL ADVISOR REVIEWED THIS INCIDENT AND CONCLUDED THAT THERE IS NO MEDICAL EVIDENCE TO SUPPORT ANY RELATIONSHIP BETWEEN THE USE OF IV-PREP WIPES AND THIS PATIENT'S SYMPTOMS.

    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). CUSTOMER'S DAUGHTER EXPERIENCED SEVERE INFECTION AT PUMP SITE. SITE WAS RED, HARD AND HAD TO BE LANCED AT HOSPITAL AND DRAINED OF PUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKIN PREP WIPES BANDAGE, LIQUID, SKIN PROTECTANT KMF SMITH & NEPHEW WOUND MANAGEMENT 59421200 0M180

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization