BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAREONE PEANUTS DECORATED BANDAGE

    MDR report key: 2982522 · Received February 19, 2013

    Report

    Report Number
    1038758-2013-00006
    Event Type
    Other
    Date Received
    February 19, 2013
    Date of Event
    April 9, 2012
    Report Date
    February 19, 2013
    Manufacturer
    ASO LLC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVEN THOUGH END-USER PICTURES DO NOT SHOW ANY SIGNS OF INFECTION, HE DID NOT PROVIDE ANY INFORMATION STATING WHETHER OR NOT MEDICAL TREATMENT FOR THIS ADVERSE EVENT WAS RECEIVED OR IF ANY INFECTION HAD BEEN CONFIRMED BY A MEDICAL PROFESSIONAL FROM THE USE OF THIS BANDAGE.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT WHEN SHE USED ONE OF THE BANDAGES FROM THE PACKAGE IN (B)(6), IT BURNED HER NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71143 CAREONE PEANUTS DECORATED BANDAGE ADHESIVE BANDAGE KGX ASO LLC CAR5574-072-00 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other