BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHARPOINT

    MDR report key: 3063091 · Received April 12, 2013

    Report

    Report Number
    3008845715-2013-00002
    Event Type
    Other
    Date Received
    April 12, 2013
    Date of Event
    January 12, 2013
    Report Date
    April 11, 2013
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC. DBA ANGIOTECH
    Product Code
    HOY
    PMA / PMN Number
    K880489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED WAS DISCARDED. METHOD: THE DEVICE WAS DISCARDED, NO PRODUCT EVAL CAN BE PERFORMED. RESULTS/CONCLUSIONS: THE DEVICE WAS DISCARDED. NO PRODUCT EVAL CAN BE PERFORMED. WITHOUT THE LOT CODE INFORMATION BEING PROVIDED, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED FOR CORRESPONDING ISSUES IDENTIFIED DURING THE MANUFACTURING PROCESSES OR AT FINAL INSPECTION. DUE TO LOT NUMBER WAS NOT REPORTED, A WAREHOUSE REVIEW FOR AVAILABLE INVENTORY OF THE SAME LOT WAS NOT ABLE TO BE PERFORMED.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THE PT SUSTAINED A FALL WHILE WEARING PRODUCT. PRODUCT BROKE IN TO MULTIPLE FRAGMENTS WHEN THE PT FELL, CAUSING DAMAGE TO THE ORBITAL AREA OF THE PT'S FACE. REF PR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159523 SHARPOINT EYE GARTER, CLEAR UNIVERSAL HOY SURGICAL SPECIALTIES PUERTO RICO INC. DBA ANGIOTECH G701-500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization NONE MADE AVAILABLE