BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAHOOK 1/4 HOK 10 PKG/BX 6 HKS/PKG

    MDR report key: 4549568 · Received February 24, 2015

    Report

    Report Number
    3004365956-2015-00168
    Event Type
    Malfunction
    Date Received
    February 24, 2015
    Date of Event
    December 18, 2014
    Report Date
    January 7, 2015
    Manufacturer
    TECATE
    Product Code
    GAG
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE HAS BEEN RETURNED TO THE MANUFACTURER, HOWEVER, THE INVESTIGATION RESULTS HAVE NOT BEEN SUBMITTED AT THE TIE OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    ALLEGED ISSUE: DURING A CRANIOTOMY, THE SCRUB NURSE PROCEEDED TO BEND THE PRODUCT INTO A SMALLER SIZE AND IT PROCEEDED TO BREAK. ANOTHER LOT NUMBER WORKED AND BENT WITHOUT BREAKING. THIS INCIDENT OCCURRED DURING INSPECTION/FUNCTIONALITY TESTING AND PRIOR TO USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128109 DURAHOOK 1/4 HOK 10 PKG/BX 6 HKS/PKG DURAHOOK GAG TECATE 73E1400055

    Patients

    Seq Age Sex Outcome Treatment
    1