BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDSNARE SURGICAL SUTURE PASSER 60 DEG UP

    MDR report key: 6967649 · Received October 22, 2017

    Report

    Report Number
    8043971-2017-00001
    Event Type
    Malfunction
    Date Received
    October 22, 2017
    Date of Event
    June 23, 2017
    Report Date
    July 10, 2017
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORPORATION LTD
    Product Code
    HWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERE WAS AN ALLEGED FAILURE OF THE SPEED SNARE WIRE TO ACTUATE AS A CASE TODAY AT (B)(6), PART NUMBER 110030130. LOT UNKNOWN. TAG MEDICAL OWNS DESIGN CONTROL OF THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747229 SPEEDSNARE SURGICAL SUTURE PASSER 60 DEG UP SPEEDSNARE¿ SURGICAL SUTURE PASSER 60 DEG UP HWQ T.A.G. MEDICAL PRODUCTS CORPORATION LTD 253001BSM 17D06

    Patients

    Seq Age Sex Outcome Treatment
    1