BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIENTRA SILICONE GEL BREAST IMPLANTS

    MDR report key: 20032664 · Received August 22, 2024

    Report

    Report Number
    1651189-2024-07475
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    January 8, 2021
    Report Date
    July 24, 2024
    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). ADDITIONAL INFORMATION: H6. SIENTRA WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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

    PATIENT CLAIM BREAST IMPLANT ILLNESS, SYMPTOMS: JOINT ACHE/STIFFNESS, MEMORY ISSUES, DIFFICULTY SWALLOWING, PAIN, GASTROINTESTINAL ISSUES, MUSCLE WEAKNESS, VISION ISSUES, MENSTRUAL ISSUES AND AGING OF SKIN. THERE ISN¿T AN OFFICIAL MEDICAL DIAGNOSIS FOR BREAST IMPLANT ILLNESS.

    Description of Event or Problem · 0

    PATIENT CLAIM BREAST IMPLANT ILLNESS, SYMPTOMS: JOINT ACHE/STIFFNESS, MEMORY ISSUES, DIFFICULTY SWALLOWING, PAIN, GASTROINTESTINAL ISSUES AND MUSCLE WEAKNESS . THERE ISN¿T AN OFFICIAL MEDICAL DIAGNOSIS FOR BREAST IMPLANT ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219083 SIENTRA SILICONE GEL BREAST IMPLANTS SILICONE GEL BREAST IMPLANT FTR SIENTRA INC 10621-XXXMP

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Required Intervention