BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    +IO- 5MM GUARD TROCR (KIT2 SLV) 65MM W/GAS

    MDR report key: 2133272 · Received May 11, 2011

    Report

    Report Number
    2647580-2011-00303
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 8, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K981941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK. ACCORDING TO THE REPORTER: DURING PREPARATION FOR THE SURGERY, THE SURGEON FOUND ORANGE SCRAPS (COATING) THAT HAD COME OFF THE DEVICE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 +IO- 5MM GUARD TROCR (KIT2 SLV) 65MM W/GAS DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0H0248

    Patients

    Seq Age Sex Outcome Treatment
    1