BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMESH

    MDR report key: 3716246 · Received March 20, 2014

    Report

    Report Number
    3005841068-2013-00002
    Event Type
    Injury
    Date Received
    March 20, 2014
    Date of Event
    December 13, 2013
    Report Date
    March 19, 2014
    Manufacturer
    ASPIDE MEDICAL
    Product Code
    FTL
    PMA / PMN Number
    K061445
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT PRESENTED WITH 7 TO 8 CM OPEN VENTRAL INCISIONAL HERNIA DEFECT. THE PT HAD A BMI OF (B)(6). PRIMARY CLOSURE WAS NOT POSSIBLE. A WN T1015 WAS USED AS A BRIDGE IMPLANT AND FIXATED WITH APPROX 20 - 25 INTERRUPTED SUTURES. UPON EXTUBATION THE PT HAD ONE EXTREMELY VIOLENT VALSALVA MANEUVER OR COUGH WHICH TORE THE MESH ALONG THE MIDLINE. THE PT WAS PUT BACK UNDER ANESTHESIA, THE COMPROMISED MESH REMOVED AND REPLACED WITH AN IDENTICAL MESH (T1015) BUT WITH LESS TENSION ON THE MESH. UPON EXTUBATION THE 2ND TIME THE PT AGAIN HAD A VALSALVA MANEUVER OR COUGH BUT TO A LESSER DEGREE WITHOUT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167890 SURGIMESH SURGIMESH WN FTL ASPIDE MEDICAL T1015 F03398A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention