BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH

    MDR report key: 2820102 · Received November 6, 2012

    Report

    Report Number
    2210968-2012-07036
    Event Type
    Injury
    Date Received
    November 6, 2012
    Report Date
    October 8, 2012
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO ACTUAL PRODUCT WAS RETURNED FOR EVALUATION. PHOTOS OF THE ACTUAL PRODUCT WERE RETURNED AND REVIEWED. ACCORDING TO THE PHOTOS RECEIVED THE INITIAL MESH FIXATION DID NOT APPEAR ADEQUATE WHICH COULD HAVE RESULTED IN THE PARTIAL MESH DETACHMENT DURING THE EARLY POST-OPERATIVE STAGE, DEPRIVING ANY OPPORTUNITY FOR PROPER TISSUE INCORPORATION INTO THE ENTIRE MESH.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-07035. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INTRA-PERITONEAL ONLAY MESH PLACEMENT ON (B)(6) 2012 FOR AN INCISIONAL HERNIA AFTER A CHOLECYSTECTOMY AND MESH WAS USED. THE PATIENT SHOWED UP AT THE GENERAL PRACTITIONER WITH ELEVATED INFLAMMATION DATA AND SIGNS OF DISCOMFORT BUT WITHOUT ANY RECOGNIZABLE POSTOPERATIVE DISEASE. THE PATIENT UNDERWENT A RE-OPERATION ON (B)(6) 2012. THE MESH HAD SLIPPED INTO THE HERNIA GAP ON ONE SIDE. THE MESH WAS EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIOMESH MESH, SURGICAL FTL ETHICON INC. NA DK8CSTA0

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention