BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGIMEND 3.0

    MDR report key: 3952361 · Received July 11, 2014

    Report

    Report Number
    3004170064-2014-00150
    Event Type
    Other
    Date Received
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    TEI BIOSCIENCES INC.
    Product Code
    FTM
    PMA / PMN Number
    060984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THIS DEVICE WAS REVIEWED AND EVERYTHING WAS IN ORDER.

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED ON (B)(6) 2014 FOR ABDOMINAL WALL RECONSTRUCTION. SOMETIME FOLLOWING SURGERY, THE PT HAD FLASH PULMONARY EDEMA. THE SURGEON INDICATED THE PT HAD OTHER ISSUES BUT NO SPECIFIC INFO WAS PROVIDED. IT IS NOT KNOWN IF THE DEVICE HAS BEEN EXPLANTED OR THE CURRENT CONDITION OF THE DEVICE OR THE OUTCOME FOR WHICH THE DEVICE WAS USED. IT IS NOT KNOWN WHAT THE PT'S CURRENT CONDITION IS. ALTHOUGH NO CAUSE FOR THE PULMONARY EDEMA WAS PROVIDED, IT IS NOT PROBABLE THAT THIS WAS CAUSED BY THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406889 SURGIMEND 3.0 SURGICAL MESH FTM TEI BIOSCIENCES INC. 606-300-117 1305009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| L| O