BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLTPRT PLUS 5MM-12MM TRC W/BLTGRP

    MDR report key: 1961249 · Received December 21, 2010

    Report

    Report Number
    2647580-2010-00992
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K954108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK. ACCORDING TO THE REPORTER: DURING THE SURGERY, PARTICLES WERE NOTED ON TOP OF THE VERSASEAL ON THE TROCAR. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLTPRT PLUS 5MM-12MM TRC W/BLTGRP DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P7K0177

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown