BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARIETEX COMP 3D PY 30X20CM NO THRX1

    MDR report key: 4929152 · Received July 21, 2015

    Report

    Report Number
    9615742-2015-00064
    Event Type
    Death
    Date Received
    July 21, 2015
    Report Date
    August 4, 2015
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K002699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: NO SAMPLE WAS PROVIDED FOR EVALUATION. PHOTOGRAPHS SHOW THE MESH INSIDE THE PATIENT BODY AND THE MESH FOLLOWING EXPLANTATION. THE VISUAL EXAMINATION OF THE PICTURES OF THE MESH INSIDE THE PATIENT BODY REVEAL THAT THE BOWEL PASSED THROUGH THE MESH. THE VISUAL EXAMINATION OF THE PICTURES SHOWING THE EXPLANTED MESH REVEAL THAT THERE ARE TWO HOLES. ONE IS BIGGER THAN THE OTHER AND SEEMS TO BE LOCATED WHERE THE BOWEL PASSED THROUGH (BETWEEN THE LENGTH MIDLINE AND THE EDGE). THERE ARE THREE VISIBLE SUTURE THREADS. A CUT OF THE MESH COULD ALSO BE OBSERVED FROM THE EDGE TO THE BIGGEST HOLE. FURTHERMORE ALL PICTURES SHOW A MESH WHICH TEXTILE PATTERN DOES NOT MATCH WITH THE REPORTED MESH. WITHOUT THE SAMPLE A DETAILED INVESTIGATION COULD NOT BE PERFORMED. AS NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. ALL PROCESS AND TEST CRITERIA ARE VERIFIED AS COMPLYING WITH THE FINISHED PRODUCT SPECIFICATIONS FOR ALL RELEASED LOTS. IF ADDITIONAL INFORMATION IS OBTAINED, OR THE SAMPLE IS RETURNED, WE WILL RE-OPEN THIS INVESTIGATION.

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER (B)(4). INITIAL REPORT SENT TO FDA ON (B)(6) 2015.

    Description of Event or Problem · 1

    PROCEDURE: BOWEL RESECTION. ACCORDING TO THE REPORTER, THE PATIENT WAS UNDERGOING AN ELECTIVE EXCISION OF MESH WITH SQUAMOUS CELL CARCINOMA. ON (B)(6) 2015 IT WAS DISCOVERED THAT THE PATIENT SUFFERED FROM A STRANGULATED BOWEL THROUGH A HOLE IN THE MESH. THE BOWEL WAS RESECTED AND ANASTOMOSED. THE PATIENT DEVELOPED MULTI ORGAN FAILURE AND DEMISED IN THE INTENSIVE CARE UNIT (ICU) APPROXIMATELY 31 DAYS LATER. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472570 PARIETEX COMP 3D PY 30X20CM NO THRX1 MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION PCO3020

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death