BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHEER ANTIBACTERIAL PAD

    MDR report key: 2961833 · Received February 4, 2013

    Report

    Report Number
    1038758-2013-00005
    Event Type
    Other
    Date Received
    February 4, 2013
    Date of Event
    November 9, 2012
    Report Date
    February 4, 2013
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS RECEIVED ON (B)(4) 2012; HOWEVER, IT WAS NOT UNTIL (B)(4) 2013 THAT THE MFR WAS INFORMED OF ANY POTENTIAL ADVERSE EVENT.

    Description of Event or Problem · 1

    END USE REPORTED SKIN TEAR FROM BANDAGE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46994 SHEER ANTIBACTERIAL PAD ADHESIVE BANDAGE KGX ASO LLC 72543993302 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other END USER DID NOT SPECIFY| THE TYPE OF INJURY BEING COVERED.