BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARIETEX PROGRIP PRECUT W/FLAP RIGHT

    MDR report key: 1634365 · Received March 9, 2010

    Report

    Report Number
    9615742-2010-00005
    Event Type
    Malfunction
    Date Received
    March 9, 2010
    Date of Event
    February 5, 2010
    Report Date
    February 12, 2010
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K081050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT SENT: 03/09/2010.

    Description of Event or Problem · 1

    PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: PRIOR TO APPLICATION TO THE PATIENT, THE MESH SHREDDED IN HIS HANDS. MESH FELL APART WHEN SURGEON HANDLED IT. A NEW LOT NUMBER WAS OPENED FOR THE CASE. THERE WAS NO REPORT OF PATIENT INJURY, UNANTICIPATED BLOOD/TISSUE LOSS, OR EXTENDED OPERATING ROOM TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX PROGRIP PRECUT W/FLAP RIGHT POLYESTER AND POLYLACTIC ACID MESH FTL SOFRADIM PRODUCTION SJA00707

    Patients

    Seq Age Sex Outcome Treatment
    1