BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASSIER-DUVAL TELESCOPIC IM SYSTEM

    MDR report key: 9923474 · Received April 3, 2020

    Report

    Report Number
    3000327445-2020-00001
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Date of Event
    March 5, 2020
    Report Date
    April 22, 2020
    Manufacturer
    PEGA MEDICAL INC.
    Product Code
    LXH
    PMA / PMN Number
    K041393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    - ATTACHMENT: [EVALUATION SUMMARY CIF075.PDF]

    Description of Event or Problem · 1

    THE COIL PULLER COMPONENT OF THE RESCUE TOOL OF THE FASSIER-DUVAL SYSTEM BROKE DURING USE. THE METAL FRAGMENT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389100 FASSIER-DUVAL TELESCOPIC IM SYSTEM COIL PULLER SHAFT LXH PEGA MEDICAL INC. 170109-03

    Patients

    Seq Age Sex Outcome Treatment
    1