BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRELLIFORM

    MDR report key: 9968723 · Received April 16, 2020

    Report

    Report Number
    2530154-2020-00001
    Event Type
    Injury
    Date Received
    April 16, 2020
    Date of Event
    March 13, 2020
    Report Date
    March 19, 2021
    Manufacturer
    DSM BIOMEDICAL, INC.
    Product Code
    FTM
    UDI-DI
    00081233702372
    PMA / PMN Number
    K091499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SUBMITTING A CORRECTION TO MANUFACTURER REPORT NUMBER 2530154-2020-00001, SUBMITTED VIA ESG GATEWAY ON APRIL 16, 2020. UPDATING SECTION G.4, DATE RECEIVED BY MANUFACTURER FROM 17-MAR-2020 TO 13-MAR-2020, TO ACCURATELY REFLECT THE DATE OF MANUFACTURER'S AWARENESS THAT HAD PREVIOUSLY BEEN REPORTED INCORRECTLY DUE TO A TYPOGRAPHICAL ERROR IN THE COMPLAINT MANAGEMENT SYSTEM.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE INVESTIGATION: PRODUCT/PROCESS REVIEW, BATCH RECORD REVIEW, SME INTERVIEWS TO ENSURE ALL PROPER CONTROLS WERE IMPLEMENTED AND FOLLOWED. A REVIEW OF THE 7003779 BATCH RECORD AND ITS ASSOCIATED INTERMEDIATE MANUFACTURING PROCESSES (PN 6445-41 LN 8003848, PN 6199-04 LN 8003370 AND 8003288, PN 6248-04 LN 5000877 AND 5002321) CONFIRMED THERE WERE NO DISCREPANCIES ASSOCIATED WITH THE PRODUCT THAT COULD HAVE IMPACTED PRODUCT PERFORMANCE. UPON REVIEW OF THE RISK ASSESSMENT AND CURRENT CONTROLS IN PLACE, IT WAS DETERMINED THAT THE CONTROLS REFERENCED IN THE RISK ANALYSIS REMAIN ACCEPTABLE AND APPLICABLE AT THIS TIME. WITH A DHF REVIEW AND RISK ASSESSMENT REVIEW BEING COMPLETED, ALL CONTROLS WERE CORRECTLY IMPLEMENTED AND THERE WERE NO DISCREPANCIES DURING MANUFACTURING AND NO ASSIGNABLE ROOT CAUSE CAN BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT OF UNKNOWN AGE OR WEIGHT UNDERWENT A COSMETIC PROCEDURE FOR PRIMARY BILATERAL BREAST AUGMENTATION WITH TRELLIFORM SURGICAL MESH. PATIENT HAS NO KNOWN UNDERLYING MEDICAL CONDITIONS. APPROXIMATELY 4 WEEKS FOLLOWING THE ORIGINAL SURGERY, THE PATIENT NOTED BILATERAL DEHISCENCE OF THE SURGICAL SITES AND A NON-ODOROUS SECRETION OF FLUID BELIEVED TO BE THE BREAKDOWN OF THE MESH. THE SURGEON REPORTED NO SEROMA OR INFECTION AND FELT THAT THE ISSUE WAS NOT A PROBLEM WITH THE SURGICAL MESH. NO OTHER EXPLANATION WAS GIVEN. NO CULTURES OF THE FLUID WERE OBTAINED. THE PATIENT UNDERWENT REVISION SURGERY TO HAVE THE SURGICAL MESH REMOVED AND IS CURRENTLY DOING WELL WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433972 TRELLIFORM SURGICAL MESH FTM DSM BIOMEDICAL, INC. TF0616 70033779 00081233702372

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BREAST IMPLANTS, DEVICE IDENTIFY UNKNOWN