BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE GROOVE GOLD WEIGHT

    MDR report key: 1515843 · Received October 21, 2009

    Report

    Report Number
    MW5013151
    Event Type
    Injury
    Date Received
    October 21, 2009
    Date of Event
    September 25, 2009
    Report Date
    October 21, 2009
    Manufacturer
    IOP INC.
    Product Code
    HQT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOREIGN BODY REACTION TO SUTURE GROOVE GOLD WEIGHT IMPLANT LEFT UPPER LID MADE BY IOP. PATIENT HAD CHRONIC EYELID INFLAMMATION. ON REMOVING THE WEIGHT I NOTICED MULTIPLE SMALL PIECES OF GOLD IN THE SURROUNDING CAPSULE. I HAVE HAD THREE PATIENTS WITH GOLD WEIGHTS MADE BY THE SAME COMPANY WITH CHRONIC INFLAMMATION DUE TO THE WEIGHT. I HAVE NEVER SEEN A SIMILAR REACTION WITH PREVIOUS WEIGHT BRANDS. DATES OF USE: FOUR MONTHS. 2009. DIAGNOSIS OR REASON FOR USE: LAGOPTHALMOS DUE TO FACIAL PALSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURE GROOVE GOLD WEIGHT NONE HQT IOP INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Disability CHRONIC INFLAMMATION SINCE IMPLANTATION.| REMOVAL.| IMPLANTED APPROXIMATELY FOUR MONTHS PREVIOUS TO