BEUDAMED
    FDA Adverse Event Death Summary report: N

    STYLE 168 SALINE FILLED BREAST IMPLANT

    MDR report key: 1735704 · Received June 23, 2010

    Report

    Report Number
    2024601-2010-00482
    Event Type
    Death
    Date Received
    June 23, 2010
    Date of Event
    June 15, 2008
    Report Date
    January 22, 2020
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Removal / Correction Number
    2011068-7/2/19-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Additional Manufacturer Narrative · 1

    ALLERGAN IS SUBMITTING THIS FOLLOW-UP MDR IN ACCORDANCE WITH 21 CFR 803 FOLLOWING THE RECALL OF BIOCELL® TEXTURED BREAST IMPLANTS AND TISSUE EXPANDERS IN RELATION TO THE UNCOMMON INCIDENCE OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL). ALLERGAN DID NOT SUBMIT THIS MDR WITHIN 30 DAYS OF ALLERGAN¿S DECISION TO INITIATE THE REMEDIAL ACTION. ALLERGAN HAS INITIATED AN INVESTIGATION TO ADDRESS LATE MDRS SUBMITTED RELATED TO 2011068-7/2/19-001-R.

    Additional Manufacturer Narrative · 1

    CLARIFICATION: THIS IS BEING SUBMITTED AS THE SECOND FOLLOW UP (SUPPLEMENTAL) MEDWATCH. INITIAL MEDWATCH WAS SUBMITTED ON 23/JUN/2010 AND THE FIRST SUPPLEMENTAL MEDWATCH WAS SUBMITTED ON 14/JUL/2010.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS A DIAGNOSED CASE OF ALCL AND THE DEATH OF THIS PATIENT

    Description of Event or Problem · 1

    ALLERGAN IS SUBMITTING THIS FOLLOW-UP MDR IN ACCORDANCE WITH 21 CFR 803 FOLLOWING THE RECALL OF BIOCELL® TEXTURED BREAST IMPLANTS AND TISSUE EXPANDERS IN RELATION TO THE UNCOMMON INCIDENCE OF BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL)

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS A DIAGNOSED CASE OF ALCL AND THE DEATH OF THIS PATIENT. FURTHER FOLLOW UP INFORMATION NOTED THE PATIENT RECEIVED TREATMENT THERAPY WHICH INCLUDED CHEST WALL RADIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STYLE 168 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death MISSING CONCOMITANT THERAPIES