BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIUMPH WEINGART PLIER

    MDR report key: 10693788 · Received October 16, 2020

    Report

    Report Number
    2081322-2020-00002
    Event Type
    Injury
    Date Received
    October 16, 2020
    Date of Event
    March 10, 2020
    Report Date
    March 10, 2020
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Product Code
    JEX
    UDI-DI
    00190707081621
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO ORGANIZERS, INC. BECAME AWARE ON (B)(4) 2020 OF AN INCIDENT IN (B)(4) WHERE THE TIP OF A TRIUMPH WEINGART PLIER BROKE OFF DURING USE IN THE MOUTH OF A PATIENT. THE PATIENT SUFFERED A RESULTING INJURY TO THE CHEEK AND WAS PRESCRIBED PAINKILLERS AND ANTIBIOTICS FOR TREATMENT. ORTHO ORGANIZERS RECEIVED ADVERSE EVENT REVIEW QUESTIONNAIRE FILLED OUT BY THE DENTAL CLINIC IN QUESTION. ON THE QUESTIONNAIRE, THE REPORTING DOCTOR, DR. (B)(4), RAISED CONCERN THAT MORE SERIOUS INJURY COULD HAVE OCCURED HAD THE BROKEN PIECE BEEN SWALLOWED. MANUFACTURER REQUESTED THAT THE DEVICE BE RETURNED FOR INVESTIGATION, BUT IT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE TIP OF THE TRIUMPH WEINGART PLIER BROKE OFF WHILE BEING USED IN THE MOUTH DURING ORTHODONTIC TREATMENT RESULTING IN INJURY TO THE INNER CHEEK. THE BROKEN PIECE WAS RETRIEVED WITHOUT FURTHER INCIDENT. PATIENT WAS PRESCRIBED PAINKILLERS AND ANTIBIOTICS TO TREAT THE INNER CHEEK INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155897 TRIUMPH WEINGART PLIER ORTHODONTIC PLIER JEX ORTHO ORGANIZERS, INC. 205-202 00190707081621

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention