BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 2181988 · Received June 16, 2011

    Report

    Report Number
    2647580-2011-00420
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 15, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE INITIAL REPORT SENT: (B)(4) 2011.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT THE BALLOON EXPLODED DURING THE TEST BEFORE UTILIZATION WHEN INFLATED WITH 23CC OF AIR. THE DEVICE WAS NOT USED IN THE PROCEDURE. ANOTHER DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER BLUNT TIP TROCAR 12MM DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P1C1435

    Patients

    Seq Age Sex Outcome Treatment
    1