BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGER AESTHETICS MEDICAL

    MDR report key: 21832430 · Received April 14, 2025

    Report

    Report Number
    1651189-2025-08698
    Event Type
    Injury
    Date Received
    April 14, 2025
    Date of Event
    March 25, 2025
    Report Date
    April 14, 2025
    Manufacturer
    SIENTRA INC
    Product Code
    FTR
    PMA / PMN Number
    P070004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SIENTRA COMPLAINT #: (B)(4). AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. SIENTRA WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    LEFT-SIDE MAMMOGRAPHY INDICATED RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022616 TIGER AESTHETICS MEDICAL SILICONE GEL BREAST IMPLANT FTR SIENTRA INC 10521-XXXHP

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention