BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE REAMER 56MM

    MDR report key: 4649006 · Received March 30, 2015

    Report

    Report Number
    9614497-2015-00105
    Event Type
    Malfunction
    Date Received
    March 30, 2015
    Date of Event
    February 9, 2015
    Report Date
    March 4, 2015
    Manufacturer
    GREATBATCH MEDICAL SA
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO GREATBATCH MEDICAL AND EVALUATION IS IN PROCESS. ONCE GREATBATCH MEDICAL COMPLETES THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH 3500A FORM WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THE REAMERS WERE FOUND TO BE DULL. NO PATIENT INJURY OR ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208195 LOW PROFILE REAMER 56MM REAMER SHELL HTO GREATBATCH MEDICAL SA 00-7803-090-56 79503200

    Patients

    Seq Age Sex Outcome Treatment
    1