BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QR V-PATCH

    MDR report key: 7431372 · Received April 13, 2018

    Report

    Report Number
    3011175548-2018-00365
    Event Type
    Injury
    Date Received
    April 13, 2018
    Report Date
    April 13, 2018
    Manufacturer
    ATRIUM MEDICAL
    Product Code
    FTL
    PMA / PMN Number
    K080688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 POTENTIAL LAWSUIT IN WHICH ATRIUM MEDICAL WOULD BE NAMED AS A DEFENDANT. THIS REPORT SHALL NOT BE CONSIDERED AS AN ADMISSION BY ATRIUM MEDICAL THAT THE PRODUCT DESCRIBED IN THE PRE-SUIT CLAIM AND DESCRIBED HEREIN IS OR WAS DEFECTIVE, OR THAT IT HAD ANY CAUSAL RELATIONSHIP TO ANY INJURIES ALLEGEDLY SUFFERED BY THE CLAIMANT.

    Description of Event or Problem · 1

    THIS EVENT IS DEEMED REPORTABLE BASED ON THE ALLEGATIONS IN A POTENTIAL LAWSUIT WHICH, WHILE UNSUBSTANTIATED, SUGGEST THAT A REPORTABLE EVENT MAY HAVE OCCURRED DURING USE OF ATRIUM MEDICAL¿S MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED UNSPECIFIED INJURIES AND COMPLICATIONS AS A RESULT OF THE IMPLANTATION OF THE MESH. 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 CHRONIC PAIN, INFLAMMATION, EROSION AND EXCISION OF UMBILICUS, SINUS FORMATION WITH CHRONIC DRAINAGE, AND WAS REQUIRED TO ENDURE SUBSEQUENT INVASIVE SURGERY TO REPAIR RECURRENT HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273811 C-QR V-PATCH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL 31200 404657

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention