BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIR OF LEG PLATES CFK (CODIERT)

    MDR report key: 7296980 · Received February 26, 2018

    Report

    Report Number
    8010652-2018-00005
    Event Type
    Injury
    Date Received
    February 26, 2018
    Date of Event
    February 8, 2018
    Report Date
    February 26, 2018
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    GETINGE - MAQUET SERVICE TECHNICIAN VISITED THE CLINIC AND INVESTIGATED THE PRODUCT IN QUESTION. AFTER INSPECTION OF THE LEG PLATE AND THE TABLE TOP NO PRODUCT SPECIFIC DEFECTS WHICH CONTRIBUTED TO THE INJURY WERE IDENTIFIED. THE INCIDENT IS BASED ON HUMAN CARELESSNESS. THE INCIDENT OCCURRED IN THE COURSE OF CONNECTING THE LEG PLATE TO THE TABLE TOP. NO MALFUNCTION OR DEFECT OF THE PRODUCTS COULD BE DETERMINED. IN CHAPTER 2 OF THE IFU POSSIBLE HAZARDS ARE STATED. "RISK OF INJURY! WHENEVER THE PRODUCT IS MOUNTED AND ADJUSTED, THERE IS A DANGER OF PINCHING AND SHEARING TO THE STAFF, PATIENT AND ACCESSORIES. ALWAYS ENSURE THAT NO ONE CAN BE SUBJECTED TO PINCHING OR SHEARING ACTION OR INJURED IN ANY OTHER WAY AND THAT THE ACCESSORIES DO NOT COLLIDE WITH ANY NEARBY OBJECTS." GETINGE - MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OPERATING ROOM NURSE SQUEEZED HER RIGHT INDEX FINGER ON THE LEFT LEG PLATE. THE BRUISE CAUSED A BLOOD BLISTER WHICH WAS TREATED WITH DISINFECTANT AND PLASTER. THE NURSE WAS ILL FOR THE REST OF THE DAY. NO LASTING HARM WAS REPORTED. MFG REFERENCE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140753 PAIR OF LEG PLATES CFK (CODIERT) ACCESSORIES, OPERATING-ROOM, TABLE (KIT) FWZ HOLGER ULLRICH 115067BC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other