BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19716681 · Received July 10, 2024

    Report

    Report Number
    1417592-2024-00724
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    June 5, 2024
    Report Date
    July 10, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 WHEN SHE WOKE UP, SHE NOTED THE PAD CAUSED HER "THROAT TO SWELL MAKING IT DIFFICULT TO SWALLOW" AND HER "NECK HAD WATER BLISTERS". THE CUSTOMER REPORTED THE PAD WAS USED TO COVER AN INCISION ON HER NECK. THE CUSTOMER REPORTED THE SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2024 AND SHE REPLACED THE SURGICAL DRESSING WITH THE PAD ON (B)(6) 2024 PRIOR TO GOING TO BED. THE CUSTOMER REPORTED SHE CALLED HER PHYSICIAN AFTER THE SWELLING AND "WATER BLISTERS" WERE IDENTIFIED ON THE MORNING OF (B)(6) 2024, AND HER PHYSICIAN INSTRUCTED HER TO GO TO THE EMERGENCY ROOM. THE CUSTOMER REPORTED IN THE EMERGENCY ROOM THEY ADMINISTERED "IV STEROIDS, AN ANTIHISTAMINE, AND BENADRYL". THE CUSTOMER REPORTED SHE WAS DISCHARGED HOME FROM THE EMERGENCY ROOM AFTER "A FEW HOURS" WHEN THE SWELLING HAD DECREASED. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, 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) 2024 WHEN SHE WOKE UP, SHE NOTED THE PAD CAUSED HER "THROAT TO SWELL MAKING IT DIFFICULT TO SWALLOW" AND HER "NECK HAD WATER BLISTERS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2349259 RX ADV AB W/P ADH PAD 3X4 6CT FRO MEDLINE INDUSTRIES, LP 231003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other