BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH

    MDR report key: 2082268 · Received May 9, 2011

    Report

    Report Number
    2210968-2011-00575
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 15, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ACCORDING THE VISUAL INSPECTION, THERE ARE MARKS OF PREVIOUS PLACED TACKS VISIBLE BUT IT SEEMS TO BE NOT ADEQUATE. THE CAUSE FOR ADHESION FORMATION OF THE MESH CANNOT NOT BE DETERMINED. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2011. (B)(4) ADHESION. CONCLUSION (B)(4): THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PAIN. ON (B)(6) 2011, THE PATIENT UNDERWENT REOPERATION AND IT WAS FOUND THAT THE MESH HAD ADHERED TO THE BOWEL. PATIENT WAS REPORTED TO BE DOING WELL AND RECOVERING FROM SURGERY.

    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 28 YR Required Intervention