BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 2725928 · Received September 4, 2012

    Report

    Report Number
    2020664-2012-00061
    Event Type
    Injury
    Date Received
    September 4, 2012
    Date of Event
    February 14, 2012
    Report Date
    August 6, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4) - BAERVELDT SHUNT. PMA: K955455. (B)(4) 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.

    Additional Manufacturer Narrative · 1

    (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED AT THE ONE (1) MONTH POST OPERATIVE VISIT ((B)(6) 2012) WITH OCULAR HYPERTENSION, 51MM HG. ON (B)(6) 2012, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO DISSECT THE CONJUNCTIVA WHERE A SUTURE WAS CUT IN ORDER TO RESOLVE THE HYPERTENSION. ON (B)(6) 2012, THE OCULAR HYPERTENSION, (INTRAOCULAR PRESSURE) RESOLVED, 29MMHG. ON (B)(6) 2012, THE 3 MONTH POST OP VISIT, THE DOCTOR REPORTED NO COMPLICATIONS. THE OCULAR PRESSURE WAS 12MMHG, AND RESOLVED.

    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