BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE PTFE CTD BLADE EXT INS 2.5

    MDR report key: 14219414 · Received April 26, 2022

    Report

    Report Number
    MW5109399
    Event Type
    Injury
    Date Received
    April 26, 2022
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT BURNED BILATERAL BREASTS BY PROTECTED BOVIE TIP WHILE BEING USED BY SURGEON. BOVIE TIP, CORD, GROUNDING PAD AND VALLEYLAB UNIT REMOVED FROM ROOM AFTER OCCURRENCE. BURN OCCURRED AT INCISION SITES, STERI-STRIPS APPLIED TO SITES AS NORMAL DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792091 MEDLINE PTFE CTD BLADE EXT INS 2.5 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDLINE INDUSTRIES, LP - NORTHFIELD EST0012M

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other BOVIE PENCIL - MEDLINE CUSTOMPACK| MEGADYNE BOVIE PAD| VALLEYLAB BOVIE MACHINE (KSG 141)