BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35R 6/BOX

    MDR report key: 14685599 · Received June 14, 2022

    Report

    Report Number
    3003898360-2022-00248
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    June 7, 2022
    Report Date
    June 7, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    QQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT VISISTAT 35R 6/BOX LOT# 73A2200582 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT.

    Description of Event or Problem · 0

    STAPLERS ARE JAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966226 VISISTAT 35R 6/BOX STAPLE, REMOVABLE (SKIN) QQS TELEFLEX MEDICAL 73A2200582

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown