Events

Field Safety Notices about Advantage and Advantage Fit System (Transvaginal Sling) / Lynx System (Suprapubic Sling) / Obtryx System (Curved or Halo; Transobturator Sling) / Obtryx II System with PrecisionBlue Design (Curved or Halo; Transobturator Sling) / Solyx SIS System (Single Incision Sling) / Uphold LITE Vaginal Support System with Capio SLIM / Pinnacle LITE Pelvic Floor Repair Kit (Posterior with Capio SLIM) / Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device

According to Bundesinstitut für Arzneimittel und Medizinprodukte, this field safety notices involved a device in Germany that was produced by Boston Scientific International S.A..

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
    04679/16
  • Date
    2016-06-13
  • Event Country
    Germany
  • Event Source
    BAM
  • Event Source URL
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/11/2016/04679-16_kundeninfo_en.html
  • Notes / Alerts
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
  • Extra notes in the data

Device

Advantage and Advantage Fit System (Transvaginal Sling) / Lynx System (Suprapubic Sling) / Obtryx...

Manufacturer

Boston Scientific International S.A.
  • 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
    BAM