BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMEND MP 13 CM X 25 CM X 2MM

    MDR report key: 12800270 · Received November 11, 2021

    Report

    Report Number
    3004170064-2021-00012
    Event Type
    Injury
    Date Received
    November 11, 2021
    Report Date
    May 6, 2022
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    FTM
    PMA / PMN Number
    K162965
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SURGIMEND MP (606-206-003) WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    A FACILITY REPORTED A (B)(6) FEMALE PATIENT WITH HISTORY OF MID-ABDOMINAL AND RIGHT LATERAL VENTRAL HERNIA REPAIR WITH PLASTIC SURGERY RECONSTRUCTION ((B)(6) 2021) DEVELOPED AN ABDOMINAL INFECTION. THE SURGEON BELIEVE THAT THE PATIENT DID NOT HAVE A GRAFT INFECTION, BUT SHE DEVELOPED NECROSIS OF HER ABDOMINAL WALL AT FIRST WEEK FOLLOW UP AFTER THE SURGERY. SHE WAS TREATED BY PLASTIC SURGERY ON (B)(6) 2021. ON (B)(6) 2021, A BACTERIAL CULTURE WAS TAKEN AND SHOWED POSITIVE FOR INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS. PRODUCT WAS NOT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1693824 SURGIMEND MP 13 CM X 25 CM X 2MM SURGIMEND FTM TEI BIOSCIENCES INC 2006008

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female