BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 13230702 · Received January 11, 2022

    Report

    Report Number
    9617229-2021-59787
    Event Type
    Injury
    Date Received
    January 11, 2022
    Date of Event
    May 10, 2021
    Report Date
    January 11, 2022
    Manufacturer
    UNKNOWN MANUFACTURER
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ROTILI A, FERRARI F, NICOSIA L, PESAPANE F, TABANELLI V, FIORI S, ET AL. MRI FEATURES OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA. BR J RADIOL 2021; 94; 20210093. THE EVENT OF LYMPHOMA-ALCL, SEROMA-LATE AND LUMP/NODULE ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: LYMPHOMA-ALCL.

    Description of Event or Problem · 0

    JOURNAL ARTICLE "MRI FEATURES OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA." REPORTED 11 PATIENTS WITH BIA-ALCL. THE ARTICLE ALSO STATES: ¿IN OUR INSTITUTION (EUROPEAN INSTITUTE OF ONCOLOGY), 11 PATIENTS WITH BIA- ALCL, AGED 40¿75 YEARS (MEAN AGE = 63 YEARS), WERE DIAGNOSED. OF THESE, EIGHT PRESENTED AT ONSET WITH PERIPROSTHETIC FLUID AND THREE WITH SOLID PERIPROSTHETIC MASSES WITH OR WITHOUT ASSOCIATED FLUID. THE MOST COMMONLY ENCOUNTERED SYMPTOMS WERE PAIN AND ENLARGEMENT OF BREAST WITH REDNESS (76%). IN ALL 11 CASES, THE DIAGNOSIS WAS OBTAINED BY CYTOLOGIC EXAMINATION WITH ULTRASOUND- GUIDED NEEDLE ASPIRATION; AND CONTRAST ENHANCED - MRI WITH STANDARD PROTOCOL (AXIAL TSE T2 WEIGHTED, GE 3D T1 WEIGHTED, WITH AND WITHOUT FAT- SUPPRESSION, BEFORE AND AFTER INTRAVENOUS BOLUS OF CONTRAST ENHANCEMENT) WAS SUBSEQUENTLY PERFORMED TO ASSESS THE EXTENT OF DISEASE." THE STATUS OF THE DEVICE IS UNKNOWN. THE MANUFACTURER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661924 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM UNKNOWN MANUFACTURER NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Life Threatening