BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE INSUL. COATED BLADE

    MDR report key: 3210099 · Received June 27, 2013

    Report

    Report Number
    1717344-2013-00464
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 4, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: (B)(4) 2013. EVAL OF THE RETURNED SAMPLE FOUND THE INSULATION INTACT. THERE WAS NO MISSING OR MELTED INSULATION NOTED. NO CONDITIONS WERE IDENTIFIED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE RETURNED SAMPLE DID NOT APPEAR TO HAVE BEEN USED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BLUE COATING ON THE BLADE MELTED AND FELL INSIDE THE PT. THE PIECE WAS RETRIEVED WITHOUT ANY INJURY TO THE PT. THE INCIDENT DEVICE WAS FROM A PHS BREAST ABDOMINOPLASTY MZ PACK. THE SITE WILL NOT RELEASE ANY PT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292350 EDGE INSUL. COATED BLADE ES ACCESSORY - NON STERILE GEI COVIDIEN LP 250302X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK L/N 1088777| BREAST ABDOMINOPLASTY MZ PACK: #(B)(4),