BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35W 6/BOX

    MDR report key: 14697385 · Received June 15, 2022

    Report

    Report Number
    3003898360-2022-00256
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    June 13, 2022
    Report Date
    June 13, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    QQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    (B)(4). PER DHR THE PRODUCT VISISTAT 35W 6/BOX LOT # 73F2100952 WAS MANUFACTURED ON 06/29/2021 A TOTAL OF (B)(4) PIECES. LOT WAS RELEASED ON 07/08/2021. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. REVISION OF FMEA-08-028-REV 05 WAS PERFORMED AND THE FAILURE MODE IS ALREADY INCLUDING IT, NO UPDATE IS REQUIRED. CORRECTIVE ACTIONS CANNOT BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION AND CONFIRM THE ALLEGED DEFECT. AT THIS TIME DUE THE SAMPLE IS NOT AVAILABLE IS NOT POSSIBLE TO DETERMINE THE SOURCE OF THE DEFECT REPORTED. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE THE PRODUCT SAMPLE IS NOT AVAILABLE TO PERFORM A PROPER INVESTIGATION AND DETERMINATE THE ROOT CAUSE.

    Description of Event or Problem · 0

    STAPLE JAMMING.

    Description of Event or Problem · 0

    STAPLE JAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1626958 VISISTAT 35W 6/BOX STAPLE, REMOVABLE (SKIN) QQS TELEFLEX MEDICAL 73F2100952

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown