BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH C-QUR MOSAIC

    MDR report key: 12236417 · Received July 28, 2021

    Report

    Report Number
    3011175548-2021-00799
    Event Type
    Death
    Date Received
    July 28, 2021
    Report Date
    July 27, 2021
    Product Code
    FTL
    PMA / PMN Number
    K121070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REVIEW OF THE DEVICE HISTORY RECORDS AND PRODUCT COMPLAINT DETAILS ATRIUM CAN FIND NO FAULT WITH THE PRODUCT. THIS LOT OF MESH PASSED ALL QUALITY AND PERFORMANCE REQUIREMENT. THIS REPORT IS BASED UPON ALLEGATIONS MADE IN A LAWSUIT IN WHICH ATRIUM MEDICAL IS NAMED AS A DEFENDANT.

    Description of Event or Problem · 1

    THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF ATRIUM MEDICAL¿S MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED CHRONIC PAIN, BOWEL OBSTRUCTION, RECURRENT HERNIA, ADDITIONAL REVISIONARY SURGERIES, LYSIS OF EXTENSIVE INTRA-ABDOMINAL ADHESIONS; RESECTION OF INFARCTED SMALL BOWL INCARCERATED, SEPSIS, DEATH, SCAR TISSUE, DRAINAGE AND WOUND VAC PLACEMENT. SINCE THIS IS A LEGAL MATTER, THE CASE HAS BEEN TURNED OVER TO LEGAL COUNSEL AND FURTHER INFORMATION OBTAINED THROUGH INVESTIGATION OR DISCOVERY MAY FALL UNDER THE ATTORNEY/CLIENT AND/OR WORK PRODUCT PRIVILEGE. HOWEVER, ATRIUM WILL SUPPLEMENT THIS REPORT AS APPROPRIATE IF ADDITIONAL INFORMATION COMES TO ITS ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139243 MESH C-QUR MOSAIC MESH, SURGICAL, POLYMERIC FTL 31105 10898238

    Patients

    Seq Age Sex Outcome Treatment
    1 Death