BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARIETEX PROGRIP PRECUT W/FLAP LEFT SIDE

    MDR report key: 5049541 · Received September 2, 2015

    Report

    Report Number
    9615742-2015-00081
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    August 21, 2015
    Report Date
    September 16, 2015
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K142900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY - A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN PERFORMED. THIS REVIEW CONFIRMED THAT THIS LOT OF PRODUCTS WAS RELEASED ACCORDING TO QUALITY ASSURANCE SPECIFICATIONS. VISUAL EXAMINATION OF THE RETURNED SAMPLE SHOWED THAT THE MESH WAS TORN FROM THE MIDDLE TO THE OPPOSITE EDGE OF THE FLAP. THE MESH PART AT THE OPPOSITE SIDE OF THE COLORED YARN MARKER SEEMED TO HAVE BEEN CUT. THE REPORTED CONDITION WAS CONFIRMED A SEARCH OF THE GLOBAL COMPLAINTS DATABASE REVEALED THAT THIS WAS THE ONLY REPORT ON FILE FOR THIS LOT OF PRODUCT. BASED ON INVESTIGATION AND A COMPLAINT HISTORY REVIEW, THE MANUFACTURE OF THE DEVICE IS NOT SUSPECTED. THERE IS NO INDICATION THAT THERE IS A DEFECTIVE LOT OR THAT THIS EVENT REPRESENTS AN EMERGING ADVERSE QUALITY TREND. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE RECORD WILL BE REOPENED AND REASSESSED AT THAT TIME.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE MESH RIPPED WHILE PLACING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583256 PARIETEX PROGRIP PRECUT W/FLAP LEFT SIDE MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION TEM1409GL SOL0780X

    Patients

    Seq Age Sex Outcome Treatment
    1