BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL PHACOEMULSIFICATION P ACK

    MDR report key: 928101 · Received April 3, 2007

    Report

    Report Number
    1920664-2007-00395
    Event Type
    Malfunction
    Date Received
    April 3, 2007
    Date of Event
    March 7, 2007
    Report Date
    March 7, 2007
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A VITRECTOMY PROCEDURE, THAT CUTTER FROM THIS VITRECTOMY PACK WOULD NOT CUT THE VITREOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL PHACOEMULSIFICATION P ACK BASIC POSTERIOR PACK WITH REFLUX HQC BAUSCH & LOMB, INC. NA T6136

    Patients

    Seq Age Sex Outcome Treatment
    1 *