BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 3030271 · Received March 28, 2013

    Report

    Report Number
    2024601-2013-00272
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: (B)(4) 2013. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF PAIN AS FOLLOWS: "AS EXPECTED FOLLOWING ANY INVASIVE SURGICAL PROCEDURE, PAIN OF VARYING INTENSITY AND DURATION MAY OCCUR FOLLOWING IMPLANTATION. IN ADDITION, IMPROPER SIZE, PLACEMENT, SURGICAL TECHNIQUE, OR CAPSULAR CONTRACTURE MAY RESULT IN PAIN ASSOCIATED WITH NERVE ENTRAPMENT OR INTERFERENCE WITH MUSCLE MOTION. PAIN MAY ALSO ACCOMPANY OTHER ADVERSE REACTIONS. UNEXPLAINED PAIN MUST BE PROMPTLY INVESTIGATED."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED A RIGHT SIDE PAIN. THIS FILE IS FOR THE RIGHT SIDE. SEE MFR FOR LEFT SIDE 2024601-2013-00270.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127389 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT FTR ALLERGAN NA 1709865

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention NO INFORMATION