BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 163 SALINE FILLED BREAST IMPLANT

    MDR report key: 2842518 · Received November 15, 2012

    Report

    Report Number
    2024601-2012-01257
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    November 24, 2008
    Report Date
    January 27, 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 Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE LABELING ADDRESSES THE REPORTED EVENT OF SEROMA AS FOLLOWS: (B)(4). ADD¿L DEVICE LABELING ADDRESSES SEROMA: ¿IF UNUSUAL SYMPTOMS OCCUR AFTER SURGERY, SUCH AS FEVER OR NOTICEABLE SWELLING OR REDNESS IN ONE BREAST, YOU SHOULD CONTACT YOUR SURGEON IMMEDIATELY.¿ (ALLERGAN SALINE BREAST IMPLANT LABELING). DEVICE LABELING REVIEWED: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL FOR PATIENTS IN THE A95/R95 STUDY INCLUDED IN THE LABELING FOR SALINE BREAST IMPLANTS.

    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.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED TO AN ALLERGAN EMPLOYEE THE EVENTS OF ALCL AND SEROMA. THIS EVENT WAS REPORTED INITIALLY EASR (B)(6) 2009; (B)(6) 2011 AND (B)(6) 2011 BOTH AS A SUPPLEMENTAL REPORTS.

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STYLE 163 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN NA 548191

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention