BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMEND 4.0 25X40 CM

    MDR report key: 10432019 · Received August 20, 2020

    Report

    Report Number
    3004170064-2020-00008
    Event Type
    Injury
    Date Received
    August 20, 2020
    Date of Event
    July 27, 2020
    Report Date
    March 26, 2021
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    FTM
    PMA / PMN Number
    K083898
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H10 SURGIMEND (PRODUCT ID 606-400-016) 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

    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 PHYSICIAN REPORTED A VENTRAL HERNIA REPAIR WAS PERFORMED ON (B)(6) 2020 USING SURGIMEND 20X20 TO REPAIR THE DEFECT. THE SURGIMEND MESH IMPLANTED PULLED THROUGH THE FASCIA, PRODUCT WAS STARTING TO GO AWAY, AND THE PATIENT RE-HERNIATED. THE PHYSICIAN PERFORMED A VENTRAL HERNIA REVISION ON (B)(6) 2020 AND IMPLANTED A SURGIMEND 4.0 TO REPAIR THE HERNIA. PHYSICIAN CONFIRMED THE PATIENT RE-HERNIATED AGAIN AND 4 DAYS LATER, THE SURGIMEND WAS MELTED AND GONE IN CERTAIN AREAS. A CULTURE WAS PERFORMED WITH A NEGATIVE RESULT FOR INFECTION. OTHER MFG REPORT NUMBER: 3004170064-2020-00007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895157 SURGIMEND 4.0 25X40 CM SURGIMEND FTM TEI BIOSCIENCES INC 1808006

    Patients

    Seq Age Sex Outcome Treatment
    1