BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK CEV2295A 3PK N5 FOR HOOK HANDLE

    MDR report key: 19495779 · Received June 9, 2024

    Report

    Report Number
    3003249645-2024-00025
    Event Type
    Malfunction
    Date Received
    June 9, 2024
    Report Date
    August 9, 2024
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    GEI
    PMA / PMN Number
    K210942
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE 3PK N5 HOOK FOR HOOK HANDLE (CEV2295A) HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, LOT/SERIAL NUMBER HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED AND THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. AN INVESTIGATION FOR CAUSE WAS UNABLE TO BE PERFORMED. A PROBABLE CAUSE OF THE REPORTED ISSUE IS DUE TO THE USE OF VOLTAGE THAT WAS TOO HIGH OR A PROLONGED ACTIVATION OF THE DEVICE.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT THERE WAS A DETACHMENT OF THE COATING OF THE 3PK N5 HOOK FOR HOOK HANDLE (CEV2295A), WHICH CAME LOOSE AND FELL ON THE FIELD/SITE OF OPERATION. THERE HAS NO REPORT OF PATIENT INJURY OR SURGICAL DELAY AT THIS TIME.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2124878 HOOK CEV2295A 3PK N5 FOR HOOK HANDLE PFM16 GEI INTEGRA MICROFRANCE S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown