BEUDAMED
    FDA Adverse Event Other Summary report: N

    PREVAIL PREOP PREP ANTIMICROBIAL GEL

    MDR report key: 216895 · Received April 2, 1999

    Report

    Report Number
    1423507-1999-00085
    Event Type
    Other
    Date Received
    April 2, 1999
    Date of Event
    March 3, 1999
    Report Date
    April 2, 1999
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ACCOUNT STATES THAT PT WAS DRAPED AND PREPPED. THE DR APPLIED TOO MUCH SOLUTION AND THEN USED A LAP SPONGE TO BLOT SOME OF THE SOLUTION. THE LAP SPONGE WAS PLACED NEXT TO THE PT. AS THE CAUTERY WAS ACTIVATED THE LAP SPONGE IGNITED AND THE FLAMES SEEMED TO FOLLOW THE SOLUTION ON THE PT. THE PT REC'D 1ST DEGREE BURN ON NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREVAIL PREOP PREP ANTIMICROBIAL GEL PREVAIL PREP LRO ALLEGIANCE HEALTHCARE CORP. 4VAIL 59928

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other