BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 2725953 · Received September 4, 2012

    Report

    Report Number
    2020664-2012-00062
    Event Type
    Injury
    Date Received
    September 4, 2012
    Date of Event
    February 24, 2012
    Report Date
    August 6, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4) - BAERVELDT SHUNT. THE 510K NUMBER: K955455. THE DEVICE REMAINS IMPLANTED. PRIOR TO RELEASE TO MARKET, THE SHUNT MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANT OF THE SHUNT (B)(6) 2012. AT THE ONE (1) MONTH POST OPERATIVE VISIT, (B)(6) 2012, A VITREOUS HEMORRHAGE DUE TO DIABETIC RETINOPATHY WAS OBSERVED. ON (B)(6) 2012, THE PATIENT UNDERWENT A VITRECTOMY. THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF ABBOTT MEDICAL OPTICS BG102-350

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R