BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS POSTERIOR VITRECTOMY PACK

    MDR report key: 4060368 · Received August 8, 2014

    Report

    Report Number
    1920664-2014-00167
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 1, 2014
    Report Date
    July 15, 2014
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN REQUESTED FOR EVAL; HOWEVER, IT HAS NOT YET ARRIVED. STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A USER FACILITY IN (B)(6) STATING THE POLYAMIDE SHEATH SEPARATED FROM THE TROCAR DURING SURGERY. THE PLUG HAD TO BE EXCHANGED. NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473078 STELLARIS POSTERIOR VITRECTOMY PACK STELLARIS PC HQC BAUSCH & LOMB BL5423W V2507

    Patients

    Seq Age Sex Outcome Treatment
    1