BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK SALINE IMPLANT

    MDR report key: 7622790 · Received June 20, 2018

    Report

    Report Number
    9617229-2018-04542
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Date of Event
    May 24, 2018
    Report Date
    June 20, 2018
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. DEVICE LABELING: POTENTIAL ADVERSE EVENTS THAT MAY OCCUR WITH SALINE-FILLED BREAST IMPLANT SURGERY INCLUDE: REOPERATION, PAIN, WRINKLING, ASYMMETRY, IMPLANT PALPABILITY/VISIBILITY, IMPLANT REMOVAL, CAPSULAR CONTRACTURE, CHANGES IN NIPPLE AND BREAST SENSATION, IMPLANT DISPLACEMENT/MIGRATION, IMPLANT DEFLATION, SCARRING, INFECTION, HEMATOMA/SEROMA, BREASTFEEDING COMPLICATIONS, IMPLANT EXTRUSION, NECROSIS, DELAYED WOUND HEALING, BREAST TISSUE ATROPHY/CHEST WALL DEFORMITY, CALCIUM DEPOSITS, AND LYMPHADENOPATHY.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED "LOOKS LIKE A SILICONE BEAD. [DR.] WAS ABLE TO PICK IT OFF WITH SOME DEBAKEYS." THE DEVICE WAS IMPLANTED AND REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461865 UNK SALINE IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other