BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHILON

    MDR report key: 6120858 · Received November 22, 2016

    Report

    Report Number
    6120858
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    September 22, 2016
    Report Date
    September 29, 2016
    Manufacturer
    ETHICON, LLC
    Product Code
    GAQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RETAINED SURGICAL ITEM: ETHILON 6-0 THREAD WITH PC-1 NEEDLE IN PATIENT'S LEFT CHEEK, UNDER ZYGOMATIC ARCH, VERY SUPERFICIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773259 ETHILON SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE GAQ ETHICON, LLC 6-0 ON A PC-1 NEEDLE HHB132

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other NO| NO OTHER THERAPIES