BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA PREP

    MDR report key: 6000155 · Received October 4, 2016

    Report

    Report Number
    MW5065203
    Event Type
    Injury
    Date Received
    October 4, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 4, 2016
    Manufacturer
    3M
    Product Code
    KOY
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SURGEON REQUESTED DURA-PREP DURING PROCEDURE FOR WOUND VAC APPLICATION. DURA-PREP APPLIED TO THE PT'S ABDOMEN. RESIDENT REQUESTED BOVIE CAUTERY DEVICE TO ADDRESS A SMALL BLEEDER. BOVIE WAS USED AND STAFF OBSERVED A SMALL FLAME APPEAR ON THE DRAPE. THE DRAPE WAS LIFTED IMMEDIATELY AND NORMAL SALINE FROM THE FIELD WAS APPLIED TO THE FRAME WITHIN 2 SECONDS. NO PT R HEALTHCARE PROVIDER OR STAFF INJURIES OCCURRED. IS THE PRODUCT COMPOUNDED? NO. IS THE PRODUCT OVER-THE-COUNTER? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650197 DURA PREP DURA PREP KOY 3M
    650198 MEGADYNE BOVIE CAUTERY DEVICE GEI MEGADYNE 0035H

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention