BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10821913 · Received November 11, 2020

    Report

    Report Number
    3004170064-2020-00012
    Event Type
    Injury
    Date Received
    November 11, 2020
    Report Date
    March 26, 2021
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    FTM
    PMA / PMN Number
    K171357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SURGIMEND WAS NOT RETURNED FOR EVALUATION (REMAINS IMPLANTED); 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.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED THE PATIENT DEVELOPED HYPERSENSITIVITY (SKIN SEEMED TO BE IRRITATED, ERYTHEMA) AFTER SURGIMEND PLACEMENT FOR PECTORAL BREAST RECONSTRUCTION. IT APPEARED ONCE AND IT WAS CONTINUOUS FOR ABOUT THREE WEEKS. THE PATIENT DEVELOPED A HOLE IN THE SKIN AND REMOVAL OF THE IMPLANT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289689 SURGIMEND PRS MESHED 20CM X 10CM X 1MM INTL SURGIMEND FTM TEI BIOSCIENCES INC 1901019

    Patients

    Seq Age Sex Outcome Treatment
    1