BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREG SLINGSHOT SHOULDER IMMOBILIZER

    MDR report key: 14490830 · Received May 24, 2022

    Report

    Report Number
    2028253-2022-00003
    Event Type
    Injury
    Date Received
    May 24, 2022
    Date of Event
    January 6, 2022
    Report Date
    May 13, 2022
    Manufacturer
    BREG, INC.
    Product Code
    ILI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF INTERNAL COMPLAINT FILES FROM DATE OF INCIDENT TO DATE OF THIS REPORT IDENTIFIED NO OTHER OR SIMILAR REPORTS FOR THIS ALLEGED INCIDENT. NO INVESTIGATION POSSIBLE, NO CONTACT INFORMATION IS AVAILABLE, NO INDICATION THAT PRODUCT IS AVAILABLE FOR RETURN. UNABLE TO CONFIRM THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT IS A BREG DEVICE.

    Description of Event or Problem · 0

    ON APRIL 29, 2022, BREG INC. RECEIVED A MEDWATCH REPORT ALLEGING HYPERESTHESIA ON FOREARM AND NERVE COMPRESSION INJURY ON PATIENT'S THUMB FROM BEING FITTED POSTOPERATIVELY WITH A BREG SLINGSHOT SHOULDER IMMOBILIZER WITH ABDUCTION PILLOW 10 DAYS AFTER UNDERGOING A ROTATOR CUFF REPAIR AND BICEPS TENODESIS PROCEDURE. CURRENT CONDITION OF PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488602 BREG SLINGSHOT SHOULDER IMMOBILIZER SLING, ARM ILI BREG, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability