BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH

    MDR report key: 2992243 · Received March 7, 2013

    Report

    Report Number
    2210968-2013-02112
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 13, 2013
    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: PHOTOS OF THE ACTUAL DEVICE INVOLVED IN THIS EVENT WERE SENT FOR EVALUATION. ACCORDING TO THE PHOTOS AND THE EXPLANTED MESH RECEIVED, THE FIXATION OF THE MESH IS CONSIDERED TO BE INAPPROPRIATE AND INADEQUATE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: 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 INCARCERATED VENTRAL HERNIA REPAIR ON (B)(6) 2012 AND MESH WAS IMPLANTED. THE PATIENT UNDERWENT A REOPERATION ON (B)(6) 2013. DURING THE PROCEDURE IT WAS NOTED THAT THERE WERE ADHESIONS TO THE INTESTINAL WALL. THE MESH WAS FOLDED AND THERE WAS NOT SUFFICIENT TISSUE INGROWTH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97709 PHYSIOMESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention