BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10894752 · Received November 24, 2020

    Report

    Report Number
    3004170064-2020-00017
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    October 18, 2020
    Report Date
    March 26, 2021
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    OXH
    PMA / PMN Number
    K171357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SURGIMEND (PRODUCT ID 606-907-001) WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ANOMALIES. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER 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

    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 A SURGIMEND WITH GREY PARTS: THE MESH WAS OPENED AND HYDRATED. A "PURSESTRING" TECHNIQUE WAS USED TO WRAP THE IMPLANT ON THE BACK TABLE. IT WAS THEN OBSERVED THAT THE MESH HAD GREY PARTS WITHIN IT. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT MESH. NO PATIENT CONTACT/INJURY REPORTED, AND THE EVENT LED TO AROUND 30 MINUTES SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355626 SURGIMEND PRS MESHED 20CM X 10CM X 1MM INTL SURGIMEND OXH TEI BIOSCIENCES INC 2001021

    Patients

    Seq Age Sex Outcome Treatment
    1