BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK CEV2295A 3PK N5 FOR HOOK HANDLE

    MDR report key: 20170427 · Received September 9, 2024

    Report

    Report Number
    3003249645-2024-00044
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    July 24, 2024
    Report Date
    September 9, 2024
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    GEI
    UDI-DI
    10381780092551
    PMA / PMN Number
    K210942
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE 3PK N5 HOOK FOR HOOK HANDLE (CEV2295A) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS: EVALUATION OF THE HOOKS VERIFIED THE COMPLAINT REPORTED BY THE CUSTOMER AS VALID. THE COATING OF THE COELIO HOOKS WERE MELTED, ESPECIALLY ON THE TIP SIDE. ROOT CAUSE ANALYSIS: IT WAS DETERMINED THAT THE REASON FOR THE REPORTED FAILURE WAS LIKELY DUE TO THE APPLICATION OF A VOLTAGE THAT WAS TOO HIGH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COELIO HOOKS/3PK N5 HOOK FOR HOOK HANDLE (CEV2295A) MELTED DURING USE. NO INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510410 HOOK CEV2295A 3PK N5 FOR HOOK HANDLE PFM16 GEI INTEGRA MICROFRANCE S.A.S. 10381780092551

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown