BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASSIER-DUVAL TELESCOPIC IM SYSTEM

    MDR report key: 17573419 · Received August 18, 2023

    Report

    Report Number
    3000327445-2023-00005
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Date of Event
    July 18, 2023
    Report Date
    July 19, 2023
    Manufacturer
    PEGA MEDICAL INC
    Product Code
    HSB
    PMA / PMN Number
    K041393
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON OF THE FAILURE OF THE FRT240 CARTRIDGE WAS DUE TO OVERTIGHTENING OF THE FRT240 HEX WHEN NOT FULLY ENGAGED INSIDE THE FEMALE COMPONENT. THE HEX WAS OVERTIGHTENED AND PRE-EXPANDED. UNDER NORMAL CIRCUMSTANCES THE HEX IS ONLY SUPPOSED TO PERMANENTLY DEFORM.

    Description of Event or Problem · 0

    THE FRT240 BROKE INSIDE THE PATIENT DURING THE EXTRACTION OF THE IMPLANT. THE BROKEN PIECES WERE NOT REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2172825 FASSIER-DUVAL TELESCOPIC IM SYSTEM 3.2 CARTRIDGE HSB PEGA MEDICAL INC E342-03&E342-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other