BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOMESH

    MDR report key: 2861412 · Received November 29, 2012

    Report

    Report Number
    2029447-2012-00002
    Event Type
    Other
    Date Received
    November 29, 2012
    Report Date
    November 28, 2012
    Manufacturer
    BIOPLATE
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER AN INTERNAL INVESTIGATION OF THE COMPLAINT, IT WAS DETERMINED THAT THE SURGEON TECHNIQUE WAS THE MOST LIKELY CAUSE OF THE ADVERSE EVENT. IT IS NOT CLEAR FROM THE REPORT THAT ADEQUATE COVERAGE WITH HEALTHY TISSUE WAS ACHIEVED, AS SPECIFIED IN THE INSTRUCTIONS FOR USE. AN ADDITIONAL SURGERY WAS SCHEDULED ON (B)(6) 2012. CORRESPONDENCE HAS BEEN SENT TO THE DISTRIBUTOR FOR INFO ON WHETHER OR NOT THE SURGERY OCCURRED AND IF SO, THE OUTCOME. THIS REPORT IS BEING SENT OUT OF AN ABUNDANCE OF CAUTION. THERE IS NO EVIDENCE OF A MALFUNCTION OF THE DEVICE. THE MOST PROBABLE CAUSE OF THE ADVERSE EVENT IS SURGEON TECHNIQUE.

    Description of Event or Problem · 1

    AFTER THE DEVICE WAS IMPLANTED IN THE PT, IT WAS NOTED THAT THE MESH WAS SEEN THROUGH THE SKIN AND A PART OF IT CAME OUT FROM THE SKIN. ALTHOUGH THE SURGEON WANTED TO REMOVE THE IMPLANT BECAUSE OF THE RISK OF INFECTION, THE PT DID NOT WANT ANOTHER SURGERY. IT IS SCHEDULED TO PERFORM ADDITIONAL PROCEDURE ON (B)(6) TO CUT UNNECESSARY PART OF THE MESH AND REMOVE THE BURR BY RASP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMESH BIOMESH JEY BIOPLATE 81-3025 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention