BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 2905363 · Received January 9, 2013

    Report

    Report Number
    2020664-2013-00003
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    April 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN FOLLOW UP THE TREATING DOCTOR INDICATED THAT HE DID NOT THINK THERE WAS A MALFUNCTION OF THE DEVICE. HE DID NOT ATTRIBUTE THE EVENT TO A DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.(B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). PRIOR TO RELEASE TO MARKET THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION EXPIRY 03/31/2013. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A (B)(6) STUDY A PATIENT HAD A GLAUCOMA SHUNT IMPLANTED. THE FOLLOWING DAY THE DOCTOR OBSERVED ''TUBE TOUCH'' TO THE CORNEA WITH HYPOTONY. THE PATIENT RECOVERED WITHOUT ANY INTERVENTION. AT ONE WEEK POST-OPERATIVE STATUS HYPHEMA AND CHOROIDAL HEMORRHAGE WERE OBSERVED. CARBAZOCHROME SODIUM SULFONATE HYDRATE AND ATROPINE SULFATE WERE ADMINISTERED. THE PATIENT HAD RECOVERED WITHIN 30 DAYS. AT THE TIME OF THE REPORT, THE DEVICE IS STILL IMPLANTED IN THE PATIENT'S EYE. IN THE HEALTH CARE PROFESSIONAL'S OPINION, THE EVENT OF THE TUBE TOUCHING THE CORNEA MAY HAVE BEEN RELATED TO A DEVICE MALFUNCTION. HOWEVER, FOR THE REST OF THE REPORTED EVENTS OF HYPOTONY, HYPHEMA, CHOROIDAL HEMORRHAGE, THE DOCTOR INDICATED THESE ARE POST-OPERATIVE COMPLICATIONS AND NOT ATTRIBUTABLE TO THE DEVICE OR THE POSSIBLE DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12667 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF ABBOTT MEDICAL OPTICS BG101-350

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention