BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LERMAN MINERVA

    MDR report key: 3207029 · Received July 1, 2013

    Report

    Report Number
    3207029
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 18, 2013
    Report Date
    July 1, 2013
    Manufacturer
    TRULIFE, INC.
    Product Code
    IQF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    AN ELDERLY PATIENT WITH C-2 VERTEBRAL BODY FRACTURE IMMOBILIZED IN LERMAN MINERVA BRACE. DESPITE PADDING AND CUSTOM FITTING DEVELOPED STAGE 3 PRESSURE ULCER ON JAW AND STAGE 2 PRESSURE ULCERS ON CLAVICLE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?IMMOBILIZATION OF CERVICAL SPINE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297718 LERMAN MINERVA ORTHOSIS, CERVICAL-THORACIC, RIGID IQF TRULIFE, INC. A193000SM *

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other| R NO OTHER THERAPIES