BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE FAST CONTROL COAGULATION SUCTION TUBE

    MDR report key: 314623 · Received February 2, 2001

    Report

    Report Number
    1044475-2001-00001
    Event Type
    Injury
    Date Received
    February 2, 2001
    Date of Event
    December 28, 2000
    Report Date
    December 28, 2000
    Manufacturer
    WECK CLOSURE SYSTEMS
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE (TONSILLECTOMY) THE PT SUSTAINED MINOR BURNS TO THE CORNERS OF LIPS. THE INJURY WAS DISCOVERED BY THE PT'S PARENT ON PT'S ARRIVAL TO STAGE II RECOVERY. CARNEX LIP BALM WAS APPLIED TO THE AFFECTED AREAS. THE PT SUSTAINED ONLY MINOR DISCOMFORT AND WAS DISCHARGED APPROXIMATELY 4 HRS AFTER SURGERY. THE OR STAFF RETRIEVED 3 ELECTROSURGICAL SUCTION COAGULATORS FROM THE TRASH AND RETURNED THEM FOR EVALUATION. THE EXACT PRODUCT USED IN THIS INCIDENT COULD NOT BE DETERMINED BY THE OR STAFF. A VALLEYLAB GENERATOR WAS USED AND SET AT 50 COAGULATION DURING THE PROCEDURE. THE PT WAS GROUNDED USING A VALLEYLAB GROUNDING PAD, CAT # E7507, LOT # 49205, EXPIRATION DATE 2002-12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4006 DISPOSABLE FAST CONTROL COAGULATION SUCTION TUBE ELECTROSURGICAL SUCTION COAGULATOR GEI WECK CLOSURE SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention