BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 22913136 · Received August 28, 2025

    Report

    Report Number
    9617229-2025-14707
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    July 21, 2025
    Report Date
    August 28, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: XU, P.; KOURENTZI, K.; WILLSON, R.; HU, H.; DEVA, A.; CAMPBELL, C.; KADIN, M. LATERAL FLOW ASSAY TO DETECT CARBONIC ANHYDRASE IX IN SEROMAS OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA. CANCERS 2025, 17, 2405. HTTPS://DOI.ORG/10.3390/CANCERS17142405. THE EVENTS OF SEROMA-LATE 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: SEROMA-LATE, LYMPHOMA-ALCL-SUSPECTED. ADDITIONAL CONTACT INFORMATION: (B)(6).

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE TITLED ¿LATERAL FLOW ASSAY TO DETECT CARBONIC ANHYDRASE IX IN SEROMAS OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA¿ HEALTHCARE PROFESSIONAL REPORTED MALIGNANT SEROMAS AND DIAGNOSIS OF BIA-ALCL. THE SAMPLING REPRESENTS 14 PATIENTS WITH SOME TYPE OF UNKNOWN ALLERGAN DEVICE. THE ORIGINAL TESTING RESULTS FOR BIA-ALCL WERE NOT PROVIDED. HOWEVER, HISTOPATHOLOGICAL MARKER OF CD30+ WAS PRESENT FOR SAMPLES DURING CONDUCTION OF THE ELISA METHOD. ALK- MARKER WAS TESTED FOR OR PROVIDED WITH SAMPLING. THE DEVICES WERE EXPLANTED. THE AFFECTED SIDE(S) ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2742540 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Life Threatening| R