BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11965030 · Received June 9, 2021

    Report

    Report Number
    3004170064-2021-00004
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Report Date
    August 24, 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

    THE SURGIMEND MESH WAS RETURNED FOR EVALUATION: THE DEVICE WAS RECEIVED TO BE DEGRADED IN A WAY THAT PREVENTS EVALUATION/INVESTIGATION OF THE ALLEGED DEFECT. FAILURE ANALYSIS COULD NOT BE COMPLETED, ROOT CAUSE CAN NOT BE DETERMINED AT THIS TIME. MANUFACTURING RECORDS DEMONSTRATE THAT THE DEVICE MET SPECIFICATIONS. A ROOT CAUSE CAN NOT BE DETERMINED. THIS CONCLUSION WAS MADE AS THE DEVICE RECEIVED DEGRADED FAR PAST THE ORIGINAL STATE THAT THE COMPLAINT WAS OBSERVED IN. THIS TYPE OF DEFECT CAN OCCUR AS A RESULT OF INADEQUATE HANDLING OF THE PRODUCT, SPECIFICALLY DURING THE HYDRATION PHASE, HOWEVER THIS CAN NOT BE CONFIRMED IN THIS CASE.

    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 WHEN THE MEDICAL STAFF OPENED THE SURGIMEND, THEY NOTICED THAT THE EDGE WAS HARD. THEY THEN REHYDRATED THE PRODUCT IN ROOM TEMPERATURE SALINE WATER AND NOTICED THAT THERE WAS EXCESSIVE POWDER IN THE WATER AND THAT THERE WERE FILAMENTS OF TISSUE DETACHED FROM THE MESH WHICH BECAME FRAGILE AND FRIABLE WHILE STRETCHING AND IT BROKE UP. NO PATIENT CONTACT/INJURY REPORTED AND THE EVENT LED TO 35 MINUTES SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862203 SURGIMEND PRS MESHED 20CM X 10CM X 1MM INTL SURGIMEND FTM TEI BIOSCIENCES INC 2004012

    Patients

    Seq Age Sex Outcome Treatment
    1