BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPLATE

    MDR report key: 22796964 · Received August 13, 2025

    Report

    Report Number
    MW5174455
    Event Type
    Injury
    Date Received
    August 13, 2025
    Report Date
    August 7, 2025
    Manufacturer
    BIOPROTECH INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING BREAST AUGMENTATION, THE PATIENT WAS BURNED ON THE LEG WHERE THE REM (RETURN ELECTRODE MONITOR) WAS PLACED. THE REM USED WAS NON-(B)(6). "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
    782278 PROPLATE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BIOPROTECH INC. P9552C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown