BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHT CORD

    MDR report key: 86004 · Received April 23, 1997

    Report

    Report Number
    MW1011182
    Event Type
    Other
    Date Received
    April 23, 1997
    Date of Event
    March 21, 1997
    Report Date
    April 23, 1997
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    FCR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THERE WERE TWO INCIDENTS OF BURNS, DISCOVERED AFTER SURGERY (3/21/97 AND 4/17/97). THE FIRST INCIDENT OCCURRED WHEN THE RETRACTOR AND LIGHT CORD WERE SEPARATED AND LEFT ON THE PT INADVERTENTLY. IN THE SECOND INCIDENT, THE CONNECTION BETWEEN THE RETRACTOR AND THE LIGHT CORD BECAME VERY HOT AND CAUSED A HALF A CENTIMETER BURN ON THE PT. ACCORDING TO THE RPTR, THE CONNECTION SHOULD NOT GET HOT. BOTH PTS WERE TREATED WITH OINTMENT AND BANDAGE. NO SCARRING OCCURRED.

    Description of Event or Problem · 2

    THERE WERE TWO INCIDENTS OF BURNS, DISCOVERED AFTER SURGERY. THE FIRST INCIDENT OCCURRED WHEN THE RETRACTOR AND LIGHT CORD WERE SEPARATED AND LEFT ON THE PT INADVERTENTLY. IN THE SECOND INCIDENT, THE CONNECTION BETWEEN THE RETRACTOR AND THE LIGHT CORD BECAME VERY HOT AND CAUSED A HALF A CENTIMETER BURN ON THE PT. ACCORDING TO THE RPTR, CONNECTION SHOWED HOT GET HOT. BOTH PTS WERE TREATED WITH OINTMENT AND BAND-AID. NO SCARRING OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHT CORD LIGHT CORD FCR RICHARD WOLF MEDICAL INSTRUMENTS CORP. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other
    2 25 YR Other