BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16592542 · Received March 22, 2023

    Report

    Report Number
    3004170064-2023-00002
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Report Date
    July 19, 2023
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    FTM
    PMA / PMN Number
    K171357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H10 SURGIMEND WAS NOT RETURNED FOR EVALUATION, HOWEVER A PICTURE WAS PROVIDED AND EVALUATED: DHR - THE LOT MET ALL ASPECTS OF THE PRODUCT SPECIFICATION AND THE PROPER MANUFACTURING STEPS AND MATERIALS WERE USED TO CREATE THIS LOT. FAILURE ANALYSIS - NO FAILURE ANALYSIS COULD BE COMPLETED FOR THIS COMPLAINT AS NO DEVICE WAS RETURNED FOR EVALUATION; HOWEVER, THIS EVENT IS CONFIRMED SINCE THE PICTURE PROVIDED BY CUSTOMER CONFIRMS THE ALLEGED DEFECT IN THE MESHING PATTERN OF THE DEVICE. ROOT CAUSE - BASED ON THE INFORMATION GIVEN BY THE CUSTOMER, A ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, THERE ARE TWO POSSIBLE ROOT CAUSES FOR THIS EVENT: DAMAGED BLADES ON THE CUTTING DIE USED TO MAKE THE MESH PATTERN, OR IMPROPER ARBOR HEIGHT ON THE DIE DUE TO IMPROPER ADJUSTMENT, INSTALLATION, OR MAINTENANCE. ADDITIONALLY, THIS EVENT IS CONFIRMED SINCE THE PICTURE PROVIDED CONFIRMS THE ALLEGED DEFECT IN THE MESHING PATTERN OF THE DEVICE. CORRECTIVE ACTIONS ARE IN PROCESS TO CORRECT THE REPORTED EVENT.

    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: "WHEN PRODUCT REMOVED FROM PACKAGING AND SOAKED PRIOR TO USE, IT BECAME APPARENT THAT THE MESHING PATTERN WAS NOT UNIFORM. IT APPEARED AS THOUGH THE PERFORATIONS WERE NOT FULL-THICKNESS IN SOME PARTS OF THE MESH (IN A DIAGONAL PATTERN). FURTHER SOAKING, AND STRETCHING DID NOT RESOLVE THIS. THE MESH OTHERWISE APPEARED NORMAL, WITH THE USUAL INTEGRITY, STRENGTH AND PLIABILITY. AS THE MAJORITY OF PERFORATIONS WERE FULL THICKNESS AND THE ISSUE DID NOT COMPROMISE ON THE OVERALL SIZE OF THE MESH WHEN STRETCHED, IT WAS DEEMED SAFE TO USE." NO PATIENT INJURY, NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843872 SURGIMEND PRS MESHED 20CM X 10CM X 1MM INTL SURGIMEND FTM TEI BIOSCIENCES INC 2202018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown