BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMO CONCEPT X PUNCH

    MDR report key: 8110919 · Received November 28, 2018

    Report

    Report Number
    9615005-2018-00002
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    November 7, 2018
    Report Date
    November 20, 2018
    Manufacturer
    FEHLING INSTRUMENTS GMBH & CO. KG
    Product Code
    HAE
    UDI-DI
    04058749086201
    PMA / PMN Number
    K153243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN A (B)(6) HOSPITAL, A PART OF A MANUAL RONGEUR (PUNCH) HAS BROKEN OFF. THE BROKEN PART WAS RETRIEVED FROM THE PATIENT. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949418 CERAMO CONCEPT X PUNCH MANUAL RONGEUR HAE FEHLING INSTRUMENTS GMBH & CO. KG TEB-2X X16L538CK 04058749086201

    Patients

    Seq Age Sex Outcome Treatment
    1