BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT BAND

    MDR report key: 15596769 · Received October 12, 2022

    Report

    Report Number
    MW5112600
    Event Type
    Injury
    Date Received
    October 12, 2022
    Date of Event
    September 15, 2022
    Report Date
    October 10, 2022
    Manufacturer
    DUTCH OPHTHALMIC USA /D.O.R.C DUTCH OPHTHALMIC RESEARCH CENTER (INTERNATIONAL) B.V.
    Product Code
    HQX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022, PATIENT HAD SURGERY FOR A LEFT EYE DETACHED RETINA. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND HAD BEEN HOSPITALIZED AT ANOTHER HEALTH SYSTEM AND UNDERWENT IMPLANT REMOVAL. PER (B)(6) 2022, OPERATIVE NOTE, SCLERAL BUCKLE BAND 42, REF 92-10, LOT 2404100 WAS PASSED 360 DEGREES UNDER EACH OF RECTUS MUSCLES AND SECURED IN THE SUPRANASAL QUADRANT USING A 70 SLEEVE, REF 92-13, LOT 2407107. ALL THE BUCKLE ELEMENTS WERE SECURED IN EACH QUADRANT USING 5-0 MERCILINE SUTURE. ON (B)(6) 2022, SURGEON SHARED THAT THE CULTURE HAD GROWN STAPH AUREUS ORGANISM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2176956 IMPLANT BAND IMPLANT, ORBITAL, EXTRA-OCULAR HQX DUTCH OPHTHALMIC USA /D.O.R.C DUTCH OPHTHALMIC RESEARCH CENTER (INTERNATIONAL) B.V. 2404100
    2176957 SLEEVE IMPLANT, ORBITAL, EXTRA-OCULAR HQX DUTCH OPHTHALMIC USA /D.O.R.C DUTCH OPHTHALMIC RESEARCH CENTER (INTERNATIONAL) B.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Hospitalization| R