BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUIKART-SIMPSON OBSTETRICAL FORCEPS

    MDR report key: 8189078 · Received December 21, 2018

    Report

    Report Number
    3007648354-2018-00001
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    August 9, 2018
    Report Date
    December 21, 2018
    Manufacturer
    FETZER MEDICAL GMBH & CO. KG
    Product Code
    HDA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL TO THE COMPANY WHO INITIATED THE INITIAL MDR THAT THE DOCTORS WERE UNABLE TO PULL THE OBSTETRICAL FORCEPS APART AND THAT THEY WERE ABLE TO REMOVE THE FORCEPS AFTER SEVERAL MINUTES. NO PATIENT WAS HARMED, THE MALFUNCTION WAS DETECTED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031025 LUIKART-SIMPSON OBSTETRICAL FORCEPS OBSTETRICAL FORCEPS HDA FETZER MEDICAL GMBH & CO. KG 46-5050 17302220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other