Events

Field Safety Notices about Lynx™ System, Suprapubic Sling, Obtryx™ System

According to Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, this field safety notices involved a device in Czechia that was produced by Boston Scientific Corporation.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
    628
  • Date
    2016-06-29
  • Event Country
    Czechia
  • Event Source
    MHSIDCCCDMIS
  • Event Source URL
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • Notes / Alerts
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and the Czech Republic.
  • Extra notes in the data

Device

Lynx™ System, Suprapubic Sling, Obtryx™ System
  • Model / Serial
    Model Number: viz seznam soucasti FSN Product Description UPN AdvantageTM System M0068502000 AdvantageTM System, 5-Pack M006850200051 Advantage FitTM System M0068502110 Advantage FitTM System, 5-Pack M0068502111 LynxTM System M0068503000 LynxTM System, 5-Pack M0068503001 ObtryxTM System, Curved M0068504000 ObtryxTM System, Curved 5-Pack M0068504001 ObtryxTM System, Halo M0068505000 ObtryxTM System, Halo 5-Pack M0068505001 ObtryxTM II System with PrecisionBlueTM Design, Curved M0068504110 ObtryxTM II System with PrecisionBlueTM Design, Curved 5-Pack M0068504111 ObtryxTM II System with PrecisionBlueTM Design, Halo M0068505110 ObtryxTM II System with PrecisionBlueTM Design, Halo 5-Pack M0068505111 Solyx™ SIS System M0068507000 Solyx™ SIS System, 5-Pack M0068507001 UpholdTM LITE Vaginal Support System with CapioTM SLIM M0068318170 PinnacleTM LITE Pelvic Floor Repair Kit, Posterior with CapioTM SLIM M0068318150 UpsylonTM Y Mesh Kit with ColpassistTM Vaginal Positioning Device M0068318220 Product Description UPN XenformTM Soft Tissue Repair Matrix, 2cm x 7cm M0068302410 XenformTM Soft Tissue Repair Matrix, 4cm x 7cm M0068302430 XenformTM Soft Tissue Repair Matrix, 6cm x 10cm M0068302450 XenformTM Soft Tissue Repair Matrix, 8cm x 12cm M0068302470
  • Product Description
    Inactive implantable medical devices
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    MHSIDCCCDMIS