BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIMEND PRS MESHED 20CM X 10CM X 1MM INTL

    MDR report key: 11198505 · Received January 19, 2021

    Report

    Report Number
    3004170064-2021-00001
    Event Type
    Malfunction
    Date Received
    January 19, 2021
    Date of Event
    December 30, 2020
    Report Date
    March 26, 2021
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    FTM
    PMA / PMN Number
    K171357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H6, H10. DEVICE HISTORY RECORD: THE DEVICE HISTORY RECORD (DHR) FOR FINISHED GOODS LOT 2005002 WAS REVIEWED, NO ANOMALIES WERE FOUND, AND ALL MANUFACTURING RELATED PROCESS STEPS WERE FOLLOWED AND DOCUMENTED PER LISTED INSTRUCTIONS AND CURRENT GOOD MANUFACTURING PRACTICES. SURGIMEND (PRODUCT ID 606-907-001) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS ON THE RETURNED PRODUCT SAMPLE CANNOT BE PERFORMED DUE TO THE STATE OF THE DEVICE. THE HYDRATED DEVICE CANNOT BE ANALYZED DUE TO THE STRUCTURAL CHANGES CAUSED BY HYDRATION AND TIME LAPSE DURING TRANSIT. FURTHERMORE, THE RETURNED DEVICE WAS TORN. ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    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 · 1

    A FACILITY REPORTED THAT THE SURGIMEND WAS REMOVED FROM THE STERILE PACKAGING AND SOAKED IN SALINE SOLUTION AT ROOM TEMPERATURE AND WHEN STRETCHED, IT WAS FRIABLE AND TORN EASILY. NO PATIENT CONTACT/INJURY REPORTED; HOWEVER, THERE WAS A SURGICAL DELAY OF 30 MINUTES DUE TO PRODUCT ISSUE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT WITHOUT ANY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88569 SURGIMEND PRS MESHED 20CM X 10CM X 1MM INTL SURGIMEND FTM TEI BIOSCIENCES INC 2005002

    Patients

    Seq Age Sex Outcome Treatment
    1