BEUDAMED
    FDA Adverse Event Other Summary report: N

    WALGREENS

    MDR report key: 3284603 · Received August 7, 2013

    Report

    Report Number
    1038758-2013-00019
    Event Type
    Other
    Date Received
    August 7, 2013
    Report Date
    August 6, 2013
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASO REVIEWED THE FOLLOWING RECORDS FOR TESTING PERFORMED ON SIMILAR LOTS OF PRODUCT. MURINE LOCAL LYMPH NODE ASSAY (LLNA) - SC EXTRACT, LOT TR-05-071-001, LOT NUMBER 200721-01. ISO INTRACUTANEOUS STUDY - EXTRACT - LOT TR-05-071-001, LOT NUMBER 200721-01. CYTOTOXICITY STUDY USING THE ISO AGAROSE OVERLAY METHOD - TR-05-071-001 - LOT NUMBER 200721-01. ALL TESTING WAS ACCEPTABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2013 END USER REPORTED THAT THE BANDAGES TORE HER SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372228 WALGREENS CLEAR WATERPROOF ANTIBACTERIAL BANDAGES KGX ASO LLC 311917142319

    Patients

    Seq Age Sex Outcome Treatment
    1 Other