BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON DET130 DEG UP 2MM 180MM

    MDR report key: 6246757 · Received January 12, 2017

    Report

    Report Number
    9610612-2017-00017
    Event Type
    Malfunction
    Date Received
    January 12, 2017
    Date of Event
    December 6, 2016
    Report Date
    January 9, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    LRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ONGOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: GERMANY. IT WAS REPORTED THAT THE TIP BROKE OFF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28731 KERRISON DET130 DEG UP 2MM 180MM BONE PUNCHES, RONGEURS LRY AESCULAP AG FK901R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other