BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19719293 · Received July 11, 2024

    Report

    Report Number
    1417592-2024-00726
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    June 13, 2024
    Report Date
    July 11, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, "THE REACTION LASTED 3 WEEKS WITH ONE WEEK UNABLE TO BARE WEIGHT. THE REACTION WAS ON THE LEFT UPPER THIGH. NOTHING WAS ON HIS SKIN WHEN IT WAS PLACED. BEING THAT I WORK IN A HOSPITAL, I WAS ABLE TO OUTPATIENT TREAT HIM, THERE DID NEED TO BE INTERVENTION AS THE BURN WAS BLISTERING AND BUBBLING. TODAY HE IS 11. HE NOW HAS A SCAR AND TINGLING SENSATION STILL WHERE THE BURN HAPPENED. TREATMENT WAS AQUACELL AG WITH COLLAGEN STRIPS CLEANED DAILY WITH WOUND WASH FOR ONE WEEK. THE NEXT WEEK WE XEROFORM THE WOUND, CONTINUED THE WOUND WASH WITH ONE DAKINS SOAK TO PREVENT MORE INFECTION APPLIED COLLAGEN FOR GROWTH AGAIN AND COVERED WITH MEPILEX FOAM BOARD. DURING THAT TIME HE NEEDED NSAIDS TO WALK THE FIRST WEEK AND THE SECOND WEEK WE HAD TO CONTINUE MORE NSAIDS UNTIL THE PAIN WAS ABOUT TO LET UP. THE WOUND TOOK OVER 2 WEEKS TO HEAL." 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, "THE REACTION LASTED 3 WEEKS WITH ONE WEEK UNABLE TO BARE WEIGHT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315471 RX ADV AB W/P ADH PAD 3X4 6CT FRO MEDLINE INDUSTRIES LP 230604

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Other