BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMEND PRS 8 CM X 16 CM SEM

    MDR report key: 20762222 · Received November 22, 2024

    Report

    Report Number
    3004170064-2024-00014
    Event Type
    Injury
    Date Received
    November 22, 2024
    Date of Event
    January 26, 2021
    Report Date
    February 27, 2025
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    FTM
    PMA / PMN Number
    K071807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE SURGIMEND SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE(S) OF THE REPORTED ISSUE 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 · 0

    INVESTIGATION UPDATE: ROOT CAUSE - NO DEFINITIVE ROOT CAUSE CAN BE IDENTIFIED FOR THIS EVENT. THE IFU FOR THIS DEVICE STATES THAT ¿GENERAL RISKS MAY INCLUDE, BUT ARE NOT LIMITED TO: INFECTION, ALLERGIC REACTIONS, PAIN, SWELLING OR BRUISING, FOREIGN BODY REACTIONS, ACUTE OR CHRONIC INFLAMMATORY REACTIONS, ADHESIONS, SEROMAS AND HEMATOMAS¿. A PROBABLE ROOT CAUSE COULD ALSO BE HYPERSENSITIVE TO COLLAGEN OR BOVINE PRODUCTS AS THE CONTRAINDICATIONS SECTION OF THE IFU STATES THAT THE DEVICE SHOULD NOT BE USED ON PATIENTS WITH A HISTORY OF HYPERSENSITIVITY TO COLLAGEN OR BOVINE PRODUCTS.

    Description of Event or Problem · 0

    STUDY: A FACILITY REPORTED: SKIN "SUFFERANCE" ON THE RECONSTRUCTED BREAST. ACTION TAKEN: SUCTION DRAIN; MEDICATION; REOPERATION, HOSPITALIZATION; RECOVERED/RESOLVED WITH SEQUELAE ON (B)(6) 2021. THE OUTCOME WAS DESCRIBED AS "RECOVERED/RESOLVED WITH SEQUELAE". SURGERY ON LEFT BREAST: MASTECTOMY'S DATE FOR CANCER ON LEFT BREAST: (B)(6) 2021. INVESTIGATOR CONSIDERS: AE RELATIONSHIP TO DEVICE: POSSIBLY. AE RELATIONSHIP TO PROCEDURE: POSSIBLY.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2601323 SURGIMEND PRS 8 CM X 16 CM SEM SURGIMEND FTM TEI BIOSCIENCES INC 1905021

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention