BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD VISITEC

    MDR report key: 1675785 · Received May 5, 2010

    Report

    Report Number
    1211998-2010-00003
    Event Type
    Other
    Date Received
    May 5, 2010
    Date of Event
    April 16, 2010
    Report Date
    April 30, 2010
    Manufacturer
    BD OPHTHALMIC SYSTEMS
    Product Code
    HNN
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLES HAVE NOT BEEN RECEIVED FROM THE CUSTOMER AT THIS TIME. A TELEPHONE CONVERSATION TO (B)(6) WAS MADE ON (B)(6) TO OBTAIN ADDITIONAL INFO. (B)(6) INDICATED THAT SAMPLE PRODUCT WAS FORWARDED TO BD FOR EVALUATION. NO OTHER COMPLAINTS FOR SOS (DLK) WERE REPORTED ON THIS PRODUCT PREVIOUSLY. HE MENTIONED THAT 8 PTS HAD SIMILAR REACTIONS DURING THE SAME WEEK BUT THOUGHT THAT IT MAY ME SOMETHING IN THEIR PROCESS. BD WILL CONDUCT ENDOTOXIN TESTING UPON THE RETURNED PRODUCT. A FOLLOW-UP REPORT WILL BE FILED IN APPROX 30 DAYS.

    Description of Event or Problem · 1

    "SOS SYNDROME (REFRACTIVE SURGERY) FOR 6 PTS AFTER USE OF THE PRODUCT. WE MAY LOOK IN OUR PROCESS IF WE DON'T HAVE ANOTHER COMPLAINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD VISITEC NUCLEUS HYDRODISSECTOR 25G 7/8 IN HNN BD OPHTHALMIC SYSTEMS NA 9215930

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention