BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35R 6/BOX

    MDR report key: 14526557 · Received May 27, 2022

    Report

    Report Number
    3003898360-2022-00184
    Event Type
    Malfunction
    Date Received
    May 27, 2022
    Date of Event
    May 17, 2022
    Report Date
    May 17, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    QQS
    UDI-DI
    24026704418194
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT VISISTAT 35R 6/BOX, LOT# 73B2200012 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT.

    Description of Event or Problem · 0

    STAPLERS MISFIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2266975 VISISTAT 35R 6/BOX STAPLE, REMOVABLE (SKIN) QQS TELEFLEX MEDICAL 73B2200012 24026704418194

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown