BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 17447241 · Received August 2, 2023

    Report

    Report Number
    9617229-2023-12796
    Event Type
    Injury
    Date Received
    August 2, 2023
    Report Date
    August 2, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Removal / Correction Number
    2011068-7/2/19-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: "JOAB RAFAEL GALVAN, FERNANDO CORDERA, RODRIGO ARRANGOIZ, LUIS PAREDES, JEAN ENRIQUE PIERZO, BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA PRESENTING AS A BREAST MASS: A CASE REPORT AND LITERATURE REVIEW, INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS, VOLUME 108, 2023, 108482, HTTPS://DOI.ORG/10.1016/J.IJSCR.2023.108482." CONTINUED E.1 ADDRESS LINE 2: MEDICAL OFFICE 515 CONTINUED H.6 HEALTH EFFECT IMPACT CODES: F2201 BIOPSY, F2203 IMAGING REQUIRED, F2303 MEDICATION REQUIRED. THE EVENTS OF BIA-ALCL, LYMPHADENOPATHY 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: BIA-ALCL, LYMPHADENOPATHY.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THROUGH THE JOURNAL ARTICLE TITLED "BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA PRESENTING AS A BREAST MASS: A CASE REPORT AND LITERATURE REVIEW", THAT A PATIENT HAD ALCL, LYMPHADENOPATHY, LUMP / NODULE THAT PRESENTED AS A MASS ON RIGHT SIDE. THE DEVICE WAS EXPLANTED. PATHOLOGY REPORT DID CONFIRM THE PRESENCE OF ALK- AND CD30+ MARKERS. PATIENT WAS TREATED WITH CHEMOTHERAPY TWO WEEKS AFTER SURGERY AND RECEIVED ADJUVANT TREATMENT WITH 6 CYCLE OF CYCLOPHOSPHAMIDE, DOXORUBICIN, CINCRISTINE, AND PREDNISONE (CHOP) PLUS IMMUNOTHERAPY (BRENTUXIMAB).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280774 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Life Threatening "ANTIHISTAMINES AS NEEDED".