BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVITEX 2S PERMANENT REINFORCED BIOSCAFFOLD

    MDR report key: 5995600 · Received October 3, 2016

    Report

    Report Number
    3007321028-2016-00001
    Event Type
    Death
    Date Received
    October 3, 2016
    Report Date
    August 31, 2016
    Manufacturer
    AROA BIOSURGERY
    Product Code
    FTM
    PMA / PMN Number
    K153632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF DEATH WAS REPORTED AS RESPIRATORY FAILURE. THERE IS NO SUSPECTED ASSOCIATION BETWEEN THE DEATH AND THE USE OF THE PRODUCT. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE EVENT. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT PASSED AWAY FOLLOWING AN EMERGENCY VENTRAL HERNIA REPAIR SURGERY PERFORMED ON (B)(6) 2016. PRIOR TO SURGERY ON (B)(6) 2016, THE PHYSICIAN PERFORMED A COMPONENT SEPARATION WHICH WAS UNSUCCESSFUL IN ACHIEVING PRIMARY CLOSURE. THE DEFECT WAS NOT REPAIRED AT THAT TIME AND THE PATIENT WAS PLACED IN THE ICU. OVITEX 2S PERMANENT REINFORCED BIOSCAFFOLD WAS USED TO BRIDGE THE DEFECT IN THE VENTRAL HERNIA REPAIR SURGERY PERFORMED ON (B)(6) 2016; THERE WERE NO REPORTED COMPLICATIONS ENCOUNTERED DURING THE SURGICAL PROCEDURE. ONE WEEK POST-OP, (B)(6) 2016, THE PHYSICIAN'S ASSISTANT REPORTED THAT THE PATIENT WAS "DOING WELL..THE INCISION IS HEALING AND HE IS SLOWLY RECOVERING." THE PATIENT PASSED AWAY SOMETIME BETWEEN (B)(6) 2016; THE EXACT DATE OF DEATH IS UNKNOWN. THE CAUSE OF DEATH WAS REPORTED AS RESPIRATORY FAILURE. THERE IS NO SUSPECTED ASSOCIATION BETWEEN THE DEATH AND THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644274 OVITEX 2S PERMANENT REINFORCED BIOSCAFFOLD SURGICAL MESH FTM AROA BIOSURGERY 2S PERMANENT SEE ATTACHED FILE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death