BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH

    MDR report key: 2070960 · Received April 27, 2011

    Report

    Report Number
    2210968-2011-00512
    Event Type
    Injury
    Date Received
    April 27, 2011
    Report Date
    April 7, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/27/2011. (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC VENTRAL HERNIA REPAIR ON AN UNKNOWN DATE AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED A RECURRENCE OF THE VENTRAL HERNIA. THE PATIENT THEN UNDERWENT AN OPEN PROCEDURE AND THE MESH WAS FOUND TO BE SCALLOPED IN BETWEEN THE TACKS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIOMESH MESH, SURGICAL, POLYMERIC FTL ETHICON NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention