BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25GA POSTERIOR PACK W AFI&FT 6BX

    MDR report key: 4870827 · Received June 24, 2015

    Report

    Report Number
    1920664-2015-00083
    Event Type
    Malfunction
    Date Received
    June 24, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 1, 2015
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT NUMBER WAS NOT PROVIDED; THEREFORE THE STERILIZATION AND LOT HISTORY RECORDS COULD NOT BE REVIEWED. REPORT 1 OF 2, SEE 1920664-2015-00084.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED DURING THE PROCEDURE, THE VITRECTOMY CUTTER DID NOT CUT. THEY REPLACED THE CUTTER WITH NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410407 STELLARIS 25GA POSTERIOR PACK W AFI&FT 6BX 25GA POSTERIOR PACK HQC BAUSCH & LOMB, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1