BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35W 6/BOX

    MDR report key: 14353817 · Received May 11, 2022

    Report

    Report Number
    3003898360-2022-00169
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    May 3, 2022
    Report Date
    May 3, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    QQS
    UDI-DI
    14026704631787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTIONS OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE DEVICE HISTORY REVIEW FOR THE PRODUCT VISISTAT 35W 6/BOX LOT# 73A2200158 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. 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 DETERMINE THE ROOT CAUSE. IF THE ALLEGED DEFECT SAMPLES BECOME AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    WE ARE CURRENTLY EXPERIENCING QUALITY ISSUES WITH THIS REFERENCE OF SKIN STAPLERS: THE STAPLES REMOVE FROM THE SKIN. SIMILAR INCIDENTS HAPPENED WITH SEVERAL STAPLERS. ADDITIONAL INFORMATION: NO PATIENT INJURY. THE STAPLES WERE NOT HOLDING PROPERLY ON THE SKIN. THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. SUTURE WITH THREADS WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870078 VISISTAT 35W 6/BOX STAPLE, REMOVABLE (SKIN) QQS TELEFLEX MEDICAL IPN028493 73A2200158 14026704631787

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown