BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBOTEX COMPOSITE MESH/20*15 CM, BOX OF 1

    MDR report key: 6335415 · Received February 16, 2017

    Report

    Report Number
    9615742-2017-00023
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Report Date
    January 24, 2017
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OXJ
    PMA / PMN Number
    K131969
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING THE PLACEMENT OF THE MESH ON THE PATIENT, THE SURGEON OBSERVED THAT THEY WERE LEFT SMALL PIECES OF COLLAGEN IN THE GLOVE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119798 SYMBOTEX COMPOSITE MESH/20*15 CM, BOX OF 1 MESH, SURGICAL, NON-ABSORBABLE, LARGE ABDOMINAL WALL DEFECTS OXJ SOFRADIM PRODUCTION SYM2015 PQC0574X

    Patients

    Seq Age Sex Outcome Treatment
    1