BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SALINE IMPLANT

    MDR report key: 2930345 · Received January 22, 2013

    Report

    Report Number
    2024601-2013-00027
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 1, 2011
    Report Date
    December 27, 2012
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SUBMITTED: (B)(4) 2013. ALLERGAN PRODUCT LABELING FOR SALINE IMPLANTS: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL, FOR PATIENTS IN THE (B)(4) STUDY, AS WELL AS THE (B)(4) STUDY ((B)(4) STUDY) INCLUDED IN THE LABELING FOR SALINE BREAST IMPLANTS.

    Description of Event or Problem · 1

    ALLERGAN'S LEGAL DEPARTMENT RECEIVED A LETTER REPORTING A PATIENT WHO HAD BILATERAL BREAST AUGMENTATION WITH MCGHAN SILICONE GEL FILLED BREAST IMPLANTS AND DIAGNOSED WITH "CB-30 POSITIVE, ALK NEGATIVE," ANAPLASTIC LARGE CELL LYMPHOMA. THERE IS LIMITED INFORMATION AVAILABLE FOR THIS CASE AFTER THE INITIAL INVESTIGATION AND HERE IS AN UNLIKELY CHANCE THAT HIS INFORMATION WILL BE OBTAINED. HOWEVER, IF THERE IS ADDITIONAL INFORMATION, SUCH AS DEVICE INFORMATION, IMPLANTING/EXPLANTING PHYSICIAN OR ANY LABS RELATED TO, BUT NOT LIMITED TO ANY COMBINED RESULTS OF IMMUNE-CHEMICAL, HISTOLOGICAL AND CYTOLOGICAL ANALYSIS OF SPECIMENS ARE SCIENTIFICALLY ACCEPTABLE CRITERIA WITH WHICH TO DIAGNOSE ALCL THE FILE WILL BE REVIEWED AND UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29513 UNK SALINE IMPLANT FWM ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention