BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH

    MDR report key: 2123956 · Received June 14, 2011

    Report

    Report Number
    2210968-2011-00775
    Event Type
    Injury
    Date Received
    June 14, 2011
    Report Date
    May 23, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 BY THE PATIENT THAT HE UNDERWENT AN INCISIONAL HERNIA REPAIR PROCEDURE ON (B)(6) 2010 AND MESH WAS USED. THE PATIENT EXPERIENCED POST OPERATIVE PAIN (B)(6) AFTER THE PROCEDURE. THE PATIENT SAW HIS SURGEON FOR THE CONTINUOUS PAIN AND WAS TOLD THAT THE PAIN WOULD EVENTUALLY GO AWAY. THE PATIENT WENT TO SEE A SECOND SURGEON (B)(6) AGO AND WAS TOLD HE HAD A RECURRENT HERNIA. THE PATIENT STATED AN XRAY WAS DONE BY THE SECOND SURGEON WHO TOLD HIM THAT THE MESH HAD COME APART AND HE NEEDED ABDOMINAL SUPPORT. THE PATIENT IS SCHEDULED FOR SURGERY FOR (B)(6) 2011.

    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