BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 10516486 · Received September 10, 2020

    Report

    Report Number
    9614546-2020-00394
    Event Type
    Injury
    Date Received
    September 10, 2020
    Report Date
    September 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: (B)(6) YRS. SEX/GENDER: FEMALE. DATE OF EVENT: UNKNOWN, NOT PROVIDED. MODEL #: UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. CATALOG#: THE CATALOG NUMBER IS UNKNOWN AS SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. SERIAL#: UNKNOWN, INFORMATION WAS NOT PROVIDED. UNIQUE IDENTIFIER: UDI# IS UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: UNKNOWN, INFORMATION WAS NOT PROVIDED. EXPLANT DATE: N/A (NOT APPLICABLE) AS THE DEVICE WAS NOT EXPLANTED. INITIAL REPORTER PHONE NUMBER: UNKNOWN, NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS (IT REMAIN IMPLANTED). THERE WAS NO SERIAL NUMBER REPORTED FOR THE DEVICE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. CITATION: JUNTTILA, L.T., LEMA, MC. G., SIEMINSKI, F.S., PROMPT VITRECTOMY FOR MANAGEMENT OF ENDOPHTHALMITIS IN SETTING OF UNEXPOSED GLAUCOMA DRAINAGE IMPLANT. AMERICAN JOURNAL OF OPHTHALMOLOGY CASE REPORTS 18 (2020) 100671. COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: PROMPT VITRECTOMY FOR MANAGEMENT OF ENDOPHTHALMITIS IN SETTING OF UNEXPOSED GLAUCOMA DRAINAGE IMPLANT. A CASE REPORT WAS DONE TO HIGHLIGHT A RARE CASE OF FULMINANT ENDOPHTHALMITIS IN THE LATE POST-OPERATIVE STAGE AFTER GLAUCOMA DRAINAGE DEVICE IMPLANTATION WITHOUT EVIDENCE OF DEVICE EXPOSURE, AND TO SHARE A UNIQUE MANAGEMENT THAT RESULTED IN SUCCESSFUL RESTORATION OF VISION AND INTRAOCULAR PRESSURE CONTROL. ONE (1) PATIENT ON BAERVELDT GLAUCOMA IMPLANT (BGI) DEVELOPED FULMINANT ENDOPHTHALMITIS WITHOUT TUBE EXPOSURE. THE PATIENT UNDERWENT PROMPT PARS PLANA VITRECTOMY AND REMOVAL OF TUBE FROM THE ANTERIOR CHAMBER WITH SUBSEQUENT RE-INSERTION AND PATCH GRAFT AS INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979622 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF JOHNSON & JOHNSON SURGICAL VISION, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention