BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH C-QUR V-PATCH

    MDR report key: 14519967 · Received May 26, 2022

    Report

    Report Number
    3011175548-2022-00147
    Event Type
    Injury
    Date Received
    May 26, 2022
    Report Date
    November 17, 2022
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    UDI-DI
    00650862312027
    PMA / PMN Number
    K090909
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WE ARE IN THE PROCESS OF PERFORMING THE INVESTIGATION AND WILL SUBMIT THE FOLLOW-UP REPORT ONCE THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    ON 10-MAY-2022, GETINGE RECEIVED AN E-MAIL FROM THE AUSTRALIAN SENIOR CUSTOMER SERVICE REPRESENTATIVE CONTAINING CUSTOMER¿S COMPLAINT THAT INVOLVES ATRIUM¿S C-QUR V-PATCH MESH PRODUCT. THE SERVICE REPRESENTATIVE REPORTED THAT THE CUSTOMER CLAIMED THAT SHE WAS A PATIENT AT STRATHFIELD PRIVATE HOSPITAL, STRATHFIELD, AU 2135 WHERE SHE HAD AN ATRIUM C-QUR V-PATCH IMPLANTED. ACCORDING TO THE E-MAIL PROVIDED THE PATIENT ALLEGEDLY HAD AN ATRIUM C-QUR V-PATCH MESH IMPLANTED AND SUBSEQUENTLY SUFFERED INFECTION AS A RESULT OF THE IMPLANTATION OF THE C-QUR V-PATCH MESH PRODUCT, WHICH REQUIRED ADDITIONAL SURGERY. THE DATE OF REVISION SURGERY IS UNKNOWN. THE LOT NUMBER AND DATE OF IMPLANT IS UNKNOWN. THE PATIENT¿S COMPLAINT CONSISTS OF GENERAL ALLEGATIONS. NO MEDICAL RECORDS OR OTHER OBJECTIVE EVIDENCE IS PROVIDED FOR REVIEW. THERE ARE NO LIABILITY CLAIM DOCUMENTS PROVIDED. NO DEVICE WAS RETURNED. BASED ON THESE FACTORS, THE COMPLAINT CANNOT BE CONFIRMED. A COMPLAINT HISTORY, COMPLAINT TREND, AND CAPA REVIEW DID NOT IDENTIFY ANY RELATED COMPLAINTS, CAPAS, OR TRENDS TO AID IN THE INVESTIGATION; HOWEVER, IT CAN BE NOTED THAT A NUMBER OF COMPLAINTS ASSOCIATED WITH MESH LITIGATION WERE IDENTIFIED. A RISK REVIEW FOUND THAT THE HAZARD/HARM (REPORTED DEFECT) AND ASSOCIATED SEVERITY IS ADEQUATELY ADDRESSED IN THE PRODUCT'S RISK MANAGEMENT FILE. NO DETAILS REGARDING THE PROCEDURE AND THE PRODUCT WERE PROVIDED. THEREFORE, IT IS UNKNOWN IF THE PRODUCT WAS USED IN ACCORDANCE WITH THE LABELING. THE IFU DISCLOSES A NUMBER OF ADVERSE REACTIONS, INCLUDING INFECTION, THAT CAN OCCUR DUE TO THE USE OF SURGICAL MESH. A DEFINITIVE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED; HOWEVER, THE CONDITIONS EXPERIENCED BY THE PATIENT ARE ANTICIPATED PROCEDURAL COMPLICATIONS. PRODUCTION OF MESH PRODUCTS WERE DISCONTINUED IN JULY 2019. AS THERE HAVE BEEN NO ADVERSE TRENDS OR NEW RISKS ASSOCIATED WITH THIS EVENT AND NO INDICATIONS OF A SUPPLIER, DESIGN, OR MANUFACTURING RELATED CAUSE, NO ESCALATION IS REQUIRED FOR THIS COMPLAINT. H3 OTHER TEXT : DEVICE NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    CUSTOMER CALL RECEIVED ON TWO DIFFERENT OCCASIONS WITH TWO DIFFERENT STORIES REGARDING A C-QUR V PATCH MESH, INJURIES MENTIONED WERE INFECTION AND ADDITIONAL SURGERY. FIRST CALL RECEIVED SHE STATED THAT SHE HAD A MESH IMPLANTED IN HER AND WANTED THE DETAILS OF BATCH NUMBER AND WHEN THE ITEM WAS SHIPPED TO THE HOSPITAL. THE SECOND CALL RECEIVED SHE CLAIMED TO BE AN INDIVIDUAL FROM (B)(6) HOSPITAL AND WANTED TO KNOW IF THE 31202 HAD BEEN RECALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2638662 MESH C-QUR V-PATCH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORPORATION 31202 00650862312027

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention