Events

Field Safety Notices about Drive Medical Products - Drive WA007 Rollators, Drive Medical Nimbo Paediatric Walkers & Endres Riviera Bathlifts

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Drive Medical Limited.

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 Number
    SN2012(03)
  • Date
    2012-04-20
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/drive-medical-products---drive-wa007-rollators-drive-medical-nimbo-paediatric-walkers-endres-riviera-bathlifts&id=d27ff825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Extra notes in the data
  • Reason
    Drive medical initiated three field safety corrective actions in august and september 2011 for the following products:  1. drive wa007 rollators  2. drive medical nimbo paediatric walkers  3. endres riviera bathlifts  the irish medicines board (imb) is aware that drive medical and their irish distributors/suppliers have been unsuccessful in their attempts to date to locate all affected devices in ireland affected by these field safety corrective actions.
  • Action
    The IMB advises that users/suppliers:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify the location of all affected products.  3. If you / your institution have affected products, follow the manufacturer’s recommendations as outlined in the attached field safety notice(s) and ensure that the corrective actions are completed on all affected medical devices.

Device

Drive Medical Products - Drive WA007 Rollators, Drive Medical Nimbo Paediatric Walkers & Endres R...
  • Model / Serial
  • Product Description
    Drive Medical Products - Drive WA007 Rollators, Drive Medical Nimbo Paediatric Walkers & Endres Riviera Bathlifts
  • Manufacturer
    Drive Medical Limited

Manufacturer

Drive Medical Limited