BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 22913085 · Received August 28, 2025

    Report

    Report Number
    9617229-2025-14706
    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 CAPSULAR CONTRACTURE 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, CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN ADDITIONAL CONTACT INFORMATION: PENG XU DEPARTMENT OF PATHOLOGY, UNIVERSITY OF VIRGINIA, CHARLOTTESVILLE, VA 22903, USA; [email protected] KATERINA KOURENTZI WILLIAM A. BROOKSHIRE DEPARTMENT OF CHEMICAL AND BIOMOLECULAR ENGINEERING, UNIVERSITY OF HOUSTON, HOUSTON, TX 77204, USA; [email protected] (K.K.) RICHARD WILLSON WILLIAM A. BROOKSHIRE DEPARTMENT OF CHEMICAL AND BIOMOLECULAR ENGINEERING, UNIVERSITY OF HOUSTON, HOUSTON, TX 77204, USA; [email protected] (K.K.) HONGHUA HU DEPARTMENT OF PLASTIC AND RECONSTRUCTIVE SURGERY, MACQUARIE UNIVERSITY, SYDNEY, NSW 2000, AUSTRALIA; [email protected] (H.H.) ANAND DEVA DEPARTMENT OF PLASTIC AND RECONSTRUCTIVE SURGERY, MACQUARIE UNIVERSITY, SYDNEY, NSW 2000, AUSTRALIA; [email protected] (H.H.) CHRISTOPHER CAMPBELL DEPARTMENT OF PLASTIC SURGERY, MAXILLOFACIAL AND ORAL HEALTH, UNIVERSITY OF VIRGINIA, CHARLOTTESVILLE, VA 22903, USA; [email protected].

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE "LATERAL FLOW ASSAY TO DETECT CARBONIC ANHYDRASE IX IN SEROMAS OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA" HEALTHCARE PROFESSIONAL REPORTED BENIGN SEROMA AND "MOST PATIENTS WITH BENIGN SEROMAS HAD CAPSULAR CONTRACTURE, A NON-MALIGNANT POSTOPERATIVE COMPLICATION". THE SAMPLING REPRESENTS 10 PATIENTS WITH SOME TYPE OF UNKNOWN ALLERGAN DEVICE. THE DEVICES WERE EXPLANTED. THE AFFECTED SIDE(S) ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698295 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention