BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIMESH

    MDR report key: 3203808 · Received June 27, 2013

    Report

    Report Number
    3005841068-2013-00004
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ASPIDE MEDICAL
    Product Code
    FTL
    PMA / PMN Number
    K120025
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LATE SUBMISSION OF THIS REPORT IS DUE TO BG MEDICAL RECLASSIFYING IT AS A POTENTIAL SERIOUS INJURY ON (B)(6) 2013, BASED UPON DISCUSSION WITH THE USER FACILITY AND THEIR CONCERN THAT A RISK FOR INFECTION COULD HAVE EXISTED. NO PATIENT INJURY OR INFECTION HAS BEEN REPORTED TO THE USER FACILITY OR BG MEDICAL AS OF THIS SUBMISSION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    TWO DAYS FOLLOWING AN OPEN VENTRAL HERNIA PROCEDURE A COMPANY CSR NOTICED THAT A PIECE OF SURGIMESH XB SKIRTED MESH HAD BEEN USED POTENTIALLY PAST ITS EXPIRATION DATE LABELED AS FEBRUARY 2013, UPON INVESTIGATION IT WAS DISCOVERED THAT THE ACCEPTABILITY OF THE XB SKIRTED MESH WAS CALLED INTO QUESTION BY THE CIRCULATING NURSE DURING THE PROCEDURE. DESPITE BEING ASKED TO MAKE SURE THE EXPIRATION DATE WAS GOOD THE DAY BEFORE BY HIS MANAGER, THE REPRESENTATIVE HAD RESPONDED TO THE DOCTOR AND OPERATING ROOM PERSONNEL THAT THE EXPIRATION DATE WAS OK. THE XB SKIRTED MESH WAS USED AND THE HERNIA REPAIRED SUCCESSFULLY WITH THE PATIENT RECOVERING UNEVENTFULLY. JUST PRIOR TO THIS EVENT ON (B)(6) 2013, ALL XB SKIRTED MESH HAD PASSED A 1 YEAR SHELF LIFE TEST AND WAS CERTIFIED FOR AN ADDITIONAL 6 MONTHS OF EXPIRATION DATING EXTENDING THE EFFECTIVE EXPIRATION DATE OF THIS DEVICE TO (B)(6) 2013. THE PATIENT WAS DOING FINE AND WITHOUT COMPLICATIONS FROM THE OPEN VENTRAL HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293157 SURGIMESH TINTRA XB SKIRTED FTL ASPIDE MEDICAL OK-1015 F07065A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other