BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROGRIP NEEDLE HOLDER STR.D:5/310MM

    MDR report key: 8187224 · Received December 20, 2018

    Report

    Report Number
    9610612-2018-00597
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    November 1, 2018
    Report Date
    December 20, 2018
    Manufacturer
    AESCULAP AG
    Product Code
    HXK
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MECHANISM OF THE NEEDLE HOLDER BROKE DURING SURGERY. DURING AN UNKNOWN PROCEDURE, WHEN THE SUTURE WAS PLACED, AN INTERNAL MECHANISM OF THE DUROGRIP NEEDLE HOLDER BROKE. THIS ISSUE CREATED A SURGICAL DELAY OF 30 MINUTES. ADDITIONAL DETAILS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024935 DUROGRIP NEEDLE HOLDER STR.D:5/310MM INSTRUMENTS HXK AESCULAP AG PL407R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other