Events

Recall of NOVABEL DERMAL FILLER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MERZ PHARMA CANADA LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    40097
  • Event Risk Class
    II
  • Event Initiated Date
    2010-07-30
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Merz global drug safety in germany has received an overall number of 70 case reports (from an estimated total number of 24000 syringes sold) in europe where the device is marketed. short term transient adverse reactions include redness bruising pain and swelling. included in these reports are 26 patients presenting with nodules and 10 patients with indurations mostly in the infra-orbital area.

Device

NOVABEL DERMAL FILLER
  • Model / Serial
    Model Catalog: MDF-100 (Lot serial: 0810004092)
  • Product Description
    MDF-100 (Novabel)
  • Manufacturer
    MERZ PHARMA CANADA LTD.

Manufacturer

MERZ PHARMA CANADA LTD.