BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH

    MDR report key: 2021298 · Received March 7, 2011

    Report

    Report Number
    2210968-2011-00238
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    November 24, 2010
    Report Date
    February 8, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2010 AND MESH WAS USED. CONCOMITANTLY, THE PT UNDERWENT A LAPAROSCOPIC EXCISION OF AN ABDOMINAL MASS FROM AN INCARCERATED OMENTUM. POST-OPERATIVELY, THE PT DEVELOPED A SEROMA, A HEMATOMA AND LOW HEMOGLOBIN. THE SEROMA AND THE HEMATOMA REC'D NO MEDICAL TREATMENT AND RESOLVED ON THEIR OWN. THE PT'S HEMOGLOBIN WAS 6.6 ON (B)(6) 2010 AND 2 UNITS OF PACKED RED BLOOD CELLS WERE GIVEN. THE PT RESPONDED VERY APPROPRIATELY AND THE HEMOGLOBIN WAS 9.2 POST TRANSFUSION. THE PT WAS GIVEN LOVENOX 40 MG PRE-OPERATIVELY FOR DEEP VEIN THROMBOSIS PROPHYLAXIS ON (B)(6) 2010. ON (B)(6) 2010, THE PT STARTED LOVENOX 30 MG TWICE DAILY AND IT WAS STOPPED ON (B)(6) 2010 SECONDARY TO THE DROP IN HEMOGLOBIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIOMESH MESH, SURGICAL FTL ETHICON, INC. NA CJ9JMSZ0

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention