BEUDAMED
    FDA Adverse Event Other Summary report: N

    3M UNIVERSAL ELECTROSURGICAL PAD

    MDR report key: 334521 · Received May 19, 2001

    Report

    Report Number
    2110898-2001-00004
    Event Type
    Other
    Date Received
    May 19, 2001
    Date of Event
    March 20, 2001
    Report Date
    May 18, 2001
    Manufacturer
    3M HEALTH CARE
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT A PT UNDERGOING AN ENDOMETRIAL RESECTION RECEIVED A THIRD DEGREE BURN ON PT'S RIGHT THIGH UNDER THE DISPERSIVE ELECTRODE. THE MEDICAL INTERVENTION INCLUDED DEBRIDEMENT OF THE BURN AND USE OF A TOPICAL OINTMENT AND WOUND DRESSING. THE DIAMETER OF THE BURN NOTED ON THE FIRST DAY WAS 6 TO 8CM. A CO REP WHO SAW THE PT 2 TO 3 DAYS LATER REPORTED THEY SAW A BLISTER ON THE RIGHT THIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23562 3M UNIVERSAL ELECTROSURGICAL PAD ELECTROSURIGCAL DISPERSIVE ELECTRODE GEI 3M HEALTH CARE NA 2003-08 CM

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other