BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ADV AB W/P XL H/DUTY 10CT

    MDR report key: 16584920 · Received March 21, 2023

    Report

    Report Number
    1417592-2023-00127
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    February 27, 2023
    Report Date
    March 21, 2023
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER ON (B)(6) 2023 AFTER DRAINING A CYST ON HER LEFT CHEEK THE CUSTOMER APPLIED A BANDAGE TO THE AFFECTED AREA AND EXPERIENCED AN "ALLERGIC REACTION WHERE THE WHITE PAD WAS PLACED". PER THE CUSTOMER "THE AREA BECAME RED, BLISTERED, AND INFLAMED". THE CUSTOMER STATED "SHE WENT TO HER PHYSICIAN AND RECEIVED A PRESCRIPTION FOR DOXYCYCLINE AND RECEIVED A CEFTRIAXONE SHOT FOR THE ALLERGIC REACTION THAT THE PHYSICIAN ASSOCIATED WITH THE USE OF THE BANDAGE". NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE SAMPLE WAS REQUESTED TO BE RETURNED FOR EVALUATION BUT HAS NOT BEEN RETURNED. 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 (B)(6) 2023 AFTER DRAINING A CYST ON HER LEFT CHEEK THE CUSTOMER APPLIED A BANDAGE TO THE AFFECTED AREA AND EXPERIENCED AN "ALLERGIC REACTION WHERE THE WHITE PAD WAS PLACED". PER THE CUSTOMER "THE AREA BECAME RED, BLISTERED, AND INFLAMED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12640 RX ADV AB W/P XL H/DUTY 10CT FRO MEDLINE INDUSTRIES, LP 20121

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other