BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35R 6/BOX

    MDR report key: 14676404 · Received June 13, 2022

    Report

    Report Number
    3003898360-2022-00246
    Event Type
    Malfunction
    Date Received
    June 13, 2022
    Date of Event
    June 7, 2022
    Report Date
    June 7, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    QQS
    UDI-DI
    14026704631770
    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

    REGULAR SKIN STAPLERS, JAMMING. THEY ALL APPEAR TO BE FROM THE SAME LOT# 73A2200582.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1582573 VISISTAT 35R 6/BOX STAPLE, REMOVABLE (SKIN) QQS TELEFLEX MEDICAL IPN028492 73A2200582 14026704631770

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown