BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANUAL SCREWDRIVER (MEDIUM) STST 0.9

    MDR report key: 16384278 · Received February 16, 2023

    Report

    Report Number
    3008261720-2022-14828
    Event Type
    Injury
    Date Received
    February 16, 2023
    Date of Event
    September 13, 2022
    Report Date
    October 10, 2022
    Manufacturer
    JJGC S.A.
    Product Code
    LRZ
    UDI-DI
    07898237563619
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THE SURGERY THE DENTIST DID NOT FOLLOW THE IFU INSTRUCTION: "BEFORE USING THIS PRODUCT, IT IS RECOMMENDED TO TIE A SAFETY THREAD IN THE HOLE TO AVOID ANY MOVEMENT OR THE RISK OF IT BEING SWALLOWED OR INHALED BY THE PATIENT." THIS WAY, THE SCREWDRIVER HAS DISLOCATED AND WAS SWALLOWED BY THE PATIENT. THE PATIENT WAS SUBMITTED TO A COLONOSCOPY TO REMOVE THE SCREWDRIVER OF THEIR INTESTINE. THE PATIENT DID NOT PRESENT ANY SYMPTOM AND IS DOING WELL AND STABLE, THERE ARE NO FURTHERS INFORMATION ABOUT THE CASE. THE EVENT DID NOT BROUGHT DAMAGES TO THE PATIENT¿S HEALTH, BUT IF RECURS THERE IS POTENTIAL TO CAUSE INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680927 MANUAL SCREWDRIVER (MEDIUM) STST 0.9 SURGICAL SCREWDRIVER, REUSABLE LRZ JJGC S.A. 104.041 07898237563619

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention