BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REM PAD

    MDR report key: 20050137 · Received August 22, 2024

    Report

    Report Number
    MW5158796
    Event Type
    Injury
    Date Received
    August 22, 2024
    Report Date
    August 20, 2024
    Manufacturer
    UNK
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, AFTER OPEN HYDROCELE WITH A LEFT INGUINAL HERNIA PROCEDURE, IN THE RECOVERY ROOM, THE PATIENT HAD AN APPROXIMATE 5X5 CM "BURN" ON THE LEFT BUTTOCK WHERE THE NON-(B)(6) REM PAD WAS APPLIED. THE OPERATION WAS CARRIED OUT ON THE RIGHT SIDE. THE PLASTIC SURGEON EXAMINED THE WOUND DIRECTLY AND NO SURGICAL INTERVENTION WAS NECESSARY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276217 REM PAD ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI UNK 20193-082 240219-0812

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Unknown