BEUDAMED
    FDA Adverse Event Other Summary report: N

    STYLUS

    MDR report key: 1220576 · Received October 31, 2008

    Report

    Report Number
    2618676-2008-00002
    Event Type
    Other
    Date Received
    October 31, 2008
    Date of Event
    June 1, 2008
    Report Date
    October 24, 2008
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO, INC. DBA ANGIOTECH
    Product Code
    HNN
    PMA / PMN Number
    K822112
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENT IS ESTIMATED. ALL OTHER PROD INFO RECORDED ON THIS FORM APPLIES TO BOTH DEVICES. THE DEVICES WERE NOT RETURNED FOR EVAL. RESULTS - THE DEVICES WERE NOT RETURNED FOR EVAL. CONCLUSIONS - RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED FOR THE FINISHED GOOD LOT NUMBERS REPORTED. NO RELEVANT FINDINGS WERE NOTED. (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLADES WERE DULL AND A CORNEAL WOUND WAS MADE LARGER THAN INTENDED AND RESULTED IN THE NEED OF A SUTURE WHICH, AS PER THE SURGEON, IS NOT UNUSUAL, BUT IS NOT THE CURRENT NORMAL PRACTICE. THE DOCTOR STATED THAT MOST CATARACT SURGERIES ARE DONE AS SUTURELESS SURGERIES. NO PT HARM OR SERIOUS DANGER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STYLUS SLIT KNIFE FULL HANDLE 2.75MM ANGLED HNN SURGICAL SPECIALTIES PUERTO RICO, INC. DBA ANGIOTECH 52-2761/52-2761 M296800/M302920

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NONE MADE AVAILABLE