BEUDAMED
    FDA Adverse Event Other Summary report: N

    CABLES, GAL300F6.0-NA-G

    MDR report key: 1559661 · Received December 11, 2009

    Report

    Report Number
    1221336-2009-00006
    Event Type
    Other
    Date Received
    December 11, 2009
    Report Date
    December 10, 2009
    Manufacturer
    INTEGRA LUXTEC, INC.
    Product Code
    EQH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT UPON FIRST USE OF THE CABLE THE PATIENT WAS BURNED. THE CUSTOMER REPORTS THAT THE SPECIFIC DEVICES USED WITH THE CABLE ARE RETRACTORS THAT WERE MANUFACTURED BY ASSI AND SNOWDEN-PENCER, AND THE LIGHT SOURCE BY DYONICS (XENON XL - (B)(4)). SEEKING ADDITIONAL INFORMATION FROM THE PHYSICIAN RE: EXTENT OF BURN AND TREATMENT. PHYSICIAN REPORTS VIA TELEPHONE 12/10/2009 THAT A BREAST IMPLANT EXCHANGE WAS BEING PERFORMED USING A LIGHTED REACTOR. THE PATIENT SUSTAINED A CUTANEOUS BURN FROM THE END OF THE CABLE THAT CONNECTS TO THE RETRACTOR. PHYSICIAN REPORTS INDETERMINATE DEGREE OF BURN. THE BURN WAS TREATED WITH OINTMENT AND A DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CABLES, GAL300F6.0-NA-G CABLES EQH INTEGRA LUXTEC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1