BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 16782202 · Received April 20, 2023

    Report

    Report Number
    9617229-2023-06539
    Event Type
    Injury
    Date Received
    April 20, 2023
    Date of Event
    March 20, 2023
    Report Date
    April 20, 2023
    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

    ARTICLE CITATION: VITTORIA, L ET AL. (2023) BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA: EVIDENCE FOR AN EFFICIENT DIAGNOSTIC WORKUP, TUMORI JOURNAL 00(0) PP. 1-8. AVAILABLE AT HTTPS://DOI.ORG/10.1177/03008916231157837. CONTRIBUTING AUTHORS: LAURA VITTORIA, LAURA SALA, VALERIA SUMMO, IOLANDA CAPONE, ELENA CONCA, MARTINA TOMA, JOSEPH OTTOLENGHI, FRANCESCA TESTA, UMBURTO CORTINOVIS, BIAGIO PAOLINI, ANTONELLO CABRAS, ANTONELLA AIELLO AND FABIO BOZZI CORRESPONDING AUTHOR: FABIO BOZZI, DEPARTMENT OF ADVANCED DIAGNOSTICS, FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI, VIA VENEZIAN I, MILAN 20133, ITALY. EMAIL: [email protected] HEALTH EFFECT IMPACT CODE: F2201 BIOPSY. THE EVENTS OF SEROMA, CAPSULAR CONTRACTURE AND LYMPHOMA-ALCL-SUSPECTED 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. THE REASON FOR REOPERATION: RUPTURE, SEROMA, CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, LYMPHOMA-ALCL-SUSPECTED.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE "BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA: EVIDENCE FOR AN EFFICIENT DIAGNOSTIC WORKUP" REPORTED THAT PATIENTS PRESENTED WITH BIA-ALCL, CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN), SEROMA, ROTATION AND RUPTURE. PATHOLOGICAL MARKER CD30+ HAS BEEN RECEIVED. PATHOLOGICAL MARKER ALK- HAS NOT BEEN RECEIVED. TREATMENT OF PATIENTS WAS NOT SPECIFIED. THE DEVICES STATUS IS UNKNOWN. AFFECTED SIDE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273654 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM UNKNOWN MANUFACTURER NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention