BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH PROLITE SHEETS

    MDR report key: 16260567 · Received January 27, 2023

    Report

    Report Number
    3011175548-2023-00028
    Event Type
    Injury
    Date Received
    January 27, 2023
    Report Date
    January 27, 2023
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    UDI-DI
    00650862300055
    PMA / PMN Number
    K930669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 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. NOT RETURNED.

    Description of Event or Problem · 0

    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 AN ATRIUM MEDICAL MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED PAIN, TRIPLE INGUINAL NEURECTOMY AND RECEIVED SENSORY BLOCKS 3 TIES OF SHORT AND LIMITED RELIEF. SINCE THIS IS A POTENTIAL 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
    902477 MESH PROLITE SHEETS MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORPORATION 1000306-00 - MESH 3X6 HERNIA REPAIR 209801 00650862300055

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention