BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35W 6/BOX

    MDR report key: 14950768 · Received July 7, 2022

    Report

    Report Number
    3003898360-2022-00303
    Event Type
    Malfunction
    Date Received
    July 7, 2022
    Date of Event
    June 13, 2022
    Report Date
    June 13, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    QQS
    UDI-DI
    14026704631787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    QN#(B)(4). REPORT NUMBER 3003898360-2022-00303 IS BEING RETRACTED BASED ON UPDATED INFORMATION.

    Description of Event or Problem · 0

    THE PACKAGE WAS FOUND BROKEN DURING INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504228 VISISTAT 35W 6/BOX STAPLE, REMOVABLE (SKIN) QQS TELEFLEX MEDICAL IPN028493 73L2100578 14026704631787

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown