BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ADV AB W/P ADH PAD 3X4 6CT

    MDR report key: 19861472 · Received July 30, 2024

    Report

    Report Number
    1417592-2024-00772
    Event Type
    Injury
    Date Received
    July 30, 2024
    Date of Event
    June 30, 2024
    Report Date
    July 30, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER ON 6/30, "AROUND 6:30 AM SUNDAY MORNING, WOKE UP TO MY SON IN PAIN AND HIS FACE SWOLLEN AND BLISTERED UNDER THE BANDAGE, AND HE HAD A LOW GRADE FEVER. THAT MORNING, I TOOK HIM STRAIGHT IN TO HIS PEDIATRICIAN TO HAVE THE BLISTERS LOOKED AT AND THEY SAID IT WAS A BURN AND PRESCRIBED HIM WITH ANTIBIOTICS AND AN ANTIBIOTIC CREAM AND SAID TO LEAVE BANDAGES OFF. SO WE DID . HE HAD A FOLLOW UP APP AT HIS PEDIATRICIAN ON TUESDAY THE 2ND OF JULY AND THEY HAD CONFIRMED IT LOOKED RAW AND WAS AT RISK FOR INFECTION DUE TO HOW BAD THE BLISTERS WERE. THE DOCTOR STATED IT LOOKED TO BE CHEMICAL BURNS . THE SAID TO KEEP APPLYING THE MEDICATION THE PRESCRIBED. MY SON WAS PRESCRIBED MUPIROCIN OINTMENT AND CEPHALEXIN ORAL ANTIBIOTICS. MY SON HAS A SQUARE SHAPED SCAR UNDER HIS CHIN WHERE THE BURNS WERE LOCATED". A SAMPLE IS AVAILABLE FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER ON 6/30, "AROUND 6:30 AM SUNDAY MORNING, WOKE UP TO MY SON IN PAIN AND HIS FACE SWOLLEN AND BLISTERED UNDER THE BANDAGE, AND HE HAD A LOW GRADE FEVER. THAT MORNING, I TOOK HIM STRAIGHT IN TO HIS PEDIATRICIAN TO HAVE THE BLISTERS LOOKED AT AND THEY SAID IT WAS A BURN AND PRESCRIBED HIM WITH ANTIBIOTICS AND AN ANTIBIOTIC CREAM AND SAID TO LEAVE BANDAGES OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245160 RX ADV AB W/P ADH PAD 3X4 6CT FRO MEDLINE INDUSTRIES LP 231002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other