Events

Alerte De Sécurité sur 4mm x 15mm small peripheral cutting balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Device, and 4mm x 15mm Flextome cutting balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Device

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Boston Scientific.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-08-01
  • Date de publication de l'événement
    2013-08-01
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130801.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: boston scientific 4mm x 15mm small peripheral cutting balloon (monorail and over-the-wire) microsurgical dilatation device, and 4mm x 15mm flextome cutting balloon (monorail and over-the-wire) microsurgical dilatation device medical device manufacturer, boston scientific, has issued a field safety notice concerning 4mm x 15mm small peripheral cutting balloon (monorail and over-the-wire) microsurgical dilatation device, and 4mm x 15mm flextome cutting balloon (monorail and over-the-wire) microsurgical dilatation device. the expiration date range from 16 november 2015 to 03 june 2016. users may experience significant difficulty or inability to remove protector cap from device which may result in damage to the device. boston scientific has received 45 complaints related to this issue from april 2013 to current date, none of which have resulted in patient injury and no additional risk to the patient is expected to occur as a result of this issue. according to the manufacturer, further distribution or use of affected products should cease immediately. users should segregate and return affected products to boston scientific. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 1 august 2013.

Device

4mm x 15mm small peripheral cutting balloon (Monorail and Over-the-Wire) Microsurgical Dilatation...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Boston Scientific 4mm x 15mm small peripheral cutting balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Device, and 4mm x 15mm Flextome cutting balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Device
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “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
    DH