BEUDAMED
    FDA Adverse Event Other Summary report: N

    WAL-MART/EQUATE

    MDR report key: 3338281 · Received August 27, 2013

    Report

    Report Number
    1038758-2013-00030
    Event Type
    Other
    Date Received
    August 27, 2013
    Report Date
    August 21, 2013
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASO REVIEWED THE FOLLOWING RECORDS FOR TESTING PERFORMED ON MATERIAL USED FOR THIS TYPE OF PRODUCT. CYTOTOXICITY STUDY USING THE ISO AGAROSE OVERLAY METHOD - SOLID - CODE: PRODUCT # XP109-E, LOT K2069-05. (B)(4). ALL TESTING WAS ACCEPTABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2013 END USER REPORTED THAT THE DEVICE BURNED LAYERS OF SKIN ON HER ARM. SHE STILL HAS THE IMPRESSION OF THE BANDAGE ON HER ARM AND CLAIMS SHE WILL ALWAYS HAVE A SCAR THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418451 WAL-MART/EQUATE HEAVY FABRIC ANTIBACTERIAL STRONG STRIPS KGX ASO LLC 078742093567

    Patients

    Seq Age Sex Outcome Treatment
    1 Other