BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 363 SALINE FILLED BREAST IMPLANT

    MDR report key: 3032437 · Received March 29, 2013

    Report

    Report Number
    2024601-2013-00218
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    November 1, 2012
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SUBMITTED ON 03/28/2013. DEVICE LABELING ADDRESS THE EVENT OF SEROMA AS: FOR PRIMARY AUGMENTATION PTS, SEROMA RATE = 1.6%. PRIMARY RECONSTRUCTION PTS = 1.0% (OTHER COMPLICATIONS). SWELLING = 7.1%. DEVICE LABELING ADDRESSES: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL FOR PTS IN THE (B)(4) 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

    HEALTH PROFESSIONAL REPORTED A LEFT SIDE SEROMA AND LYMPHOMA. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN INFO REGARDING THIS CASE. WHEN INFO IS MADE AVAILABLE, THE FILE WILL BE UPDATED AND THE INFO WILL BE FORWARDED.

    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
    130585 STYLE 363 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention NO INFO