BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFIX ABSORBABLE FIXATION SYSTEM 15

    MDR report key: 8496856 · Received April 8, 2019

    Report

    Report Number
    MW5085683
    Event Type
    Malfunction
    Date Received
    April 8, 2019
    Date of Event
    March 7, 2019
    Report Date
    April 4, 2019
    Manufacturer
    DAVOL INC., SUB. C. R. BARD, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING INGUINAL HERNIA REPAIR DURING WHICH TIME HE OPTIFIX 15 DID NOT FIRE. REMOVED FROM PT AFTER WHICH IT WAS REFIRED AND SOME OF THE ABSORBABLE FASTENERS CAME OUT. ANOTHER OPTIFIX WAS OBTAINED AND SURGERY WAS COMPLETED. NO APPARENT PT HARM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283172 OPTIFIX ABSORBABLE FIXATION SYSTEM 15 STAPLE, IMPLANTABLE GDW DAVOL INC., SUB. C. R. BARD, INC. HUCX0190

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR