BEUDAMED
    FDA Adverse Event Death Summary report: N

    C-QUR V-PATCH MESH

    MDR report key: 8120290 · Received November 30, 2018

    Report

    Report Number
    3011175548-2018-01420
    Event Type
    Death
    Date Received
    November 30, 2018
    Report Date
    November 30, 2018
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    PMA / PMN Number
    K090909
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE NOT ABLE TO THOROUGHLY INVESTIGATE THIS REPORT AS NOT LOT NUMBER WAS PROVIDED. THIS REPORT IS BASED UPON ALLEGATIONS MADE IN A LAWSUIT IN WHICH ATRIUM MEDICAL IS NAMED AS A DEFENDANT. THIS REPORT SHALL NOT BE CONSIDERED AS AN ADMISSION BY ATRIUM MEDICAL THAT THE PRODUCT DESCRIBED IN THE LAWSUIT CLAIM AND DESCRIBED HEREIN IS OR WAS DEFECTIVE, OR THAT IT HAD ANY CAUSAL RELATIONSHIP TO ANY INJURIES ALLEGEDLY SUFFERED BY THE PLAINTIFF.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: BASED ON THE REVIEW OF THE DEVICE HISTORY RECORDS, STERILITY RECORDS AND PRODUCT COMPLAINT DETAILS ATRIUM CAN FIND NO FAULT WITH THE PRODUCT. THIS LOT OF MESH PASSED ALL QUALITY AND PERFORMANCE REQUIREMENTS.

    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 INFECTION REQUIRING REMOVAL OF THE C-QUR MESH, AND DEATH. 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.

    Description of Event or Problem · 1

    PLAINTIFF ALLEGEDLY ALSO EXPERIENCED VENTRAL HERNIA, ENTEROCUTANEOUS FISTULA, DEHISCENCE, ILEUS, BOWEL RESECTION, ADHESIONS, PAIN, (B)(6), AND SEPSIS AND MULTISYSTEM FAILURE (CARDIAC, RESPIRATORY, RENAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960060 C-QUR V-PATCH MESH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORPORATION 31202 10854802

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death