BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES TEN THOUSAND MASTER

    MDR report key: 139801 · Received December 19, 1997

    Report

    Report Number
    2028159-1997-00242
    Event Type
    Injury
    Date Received
    December 19, 1997
    Report Date
    December 5, 1997
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H-10: A COMPANY REP CHECKED THE SYSTEM AND HANDPIECE AND FOUND THEM TO MEET THEIR PERFORMANCE SPECIFICATIONS. H-11: REVISED H3, H6 CODES. THIS REPORT WAS MAILED IN TO FDA ON: 01/20/1998. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 1

    SIX SUTURES WERE REQUIRED TO CLOSE WOUND. HANDPIECE WAS CHANGED TO CONTINUE PHACOEMULSIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TEN THOUSAND MASTER PHACOEMULSIFICATION-ASPIRATION SYSTEM HQE ALCON LABORATORIES, INC. STTM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other| R