BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAX GR 5X18 T5 2/0 DT

    MDR report key: 6339362 · Received February 17, 2017

    Report

    Report Number
    9612501-2017-00274
    Event Type
    Injury
    Date Received
    February 17, 2017
    Report Date
    January 23, 2017
    Manufacturer
    COVIDIEN
    Product Code
    GAM
    PMA / PMN Number
    K990951
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ACCORDING TO REPORT: SUPRACERVICAL HYSTERECTOMY WITH A AND P REPAIR BEING DONE WHEN TIP OF NEEDLE BROKE OFF AND UNABLE TO BE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121530 MAX GR 5X18 T5 2/0 DT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GAM COVIDIEN 8886622953 D6C1919X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other