BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 X 25 CM RECTANGLE MESH

    MDR report key: 17940821 · Received October 16, 2023

    Report

    Report Number
    3015194982-2023-00004
    Event Type
    Malfunction
    Date Received
    October 16, 2023
    Date of Event
    September 21, 2023
    Report Date
    December 1, 2023
    Manufacturer
    SIA INC.
    Product Code
    FTL
    PMA / PMN Number
    K181094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H10. THE DURASORB MONOFILAMENT MESH (ID (B)(6)) 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.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT "A SMALL PIECE OF PARTICULATE" WAS FOUND ON THE EDGE OF DURASORB MONOFILAMENT MESH (PTM2025). THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE AND THE EVENT LED TO 1-2 MINUTES SURGICAL DELAY.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631910 20 X 25 CM RECTANGLE MESH DURASORB MONOFILAMENT MESH FTL SIA INC. RK28353

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown