BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LESKELL RONGUER

    MDR report key: 20954084 · Received December 16, 2024

    Report

    Report Number
    MW5163692
    Event Type
    Injury
    Date Received
    December 16, 2024
    Date of Event
    December 6, 2024
    Report Date
    December 11, 2024
    Manufacturer
    SURGICAL DIRECT, INC.
    Product Code
    HAE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RONGUER BROKE DURING USE; SCREW FELL OUT OF HANDLE. ALL PIECES WERE LOCATED AND REMOVED. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227489 LESKELL RONGUER RONGUER HAE SURGICAL DIRECT, INC. SD14848-01

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention