Events

Rappel de Miramar Labs Mira Dry

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Miramar Labs Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    19582
  • Date de mise en oeuvre de l'événement
    2015-12-18
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Device Consulting (NZ) Pty, Level 4, 52 Symonds Street, Auckland 1010
  • Cause
    Manufacturer has been advised that some clinics overseas are using substances that have not been validated for use with the miradry system to lubricate the skin prior to using the miradry handpiece. this may prevent the cooling plate in the miradry handpiece from correctly contain and cooling the skin and cause minor burns and blisters., whilst there have not been any adverse events reported in australia, device consulting is conducting a product correction to update the user manual for the miradry system to include the statement:, “do not use lubricants other than the recommended lubricants k-y® jelly or k-y® liquid). use of other substances such as ultrasound gel or ipl coupling gel can reduce the effectiveness of the surface cooling, leading to blisters or burns.”.
  • Action
    Instructions for use to be updated

Device

Miramar Labs Mira Dry
  • Modèle / numéro de série
    Model: , Affected: all batches
  • Manufacturer
    Miramar Labs Inc

Manufacturer

Miramar Labs Inc