Events

Alerte De Sécurité sur Other-Sonic Generic Ultrasound Transmission Gel

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

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
    2012-04-19
  • 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_20120419.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
    Field safety notice: other-sonic generic ultrasound transmission gel the food and drug administration (fda), united states, has issued a safety communication on other-sonic generic ultrasound transmission gel manufactured by pharmaceutical innovations, inc. fda alerted that health care professionals and facilities to stop using other-sonic generic ultrasound transmission gel manufactured june through december 2011 because of bacterial contamination. the contamination was found in 250 milliliter (ml) bottles and 5 liter (l) dispensing containers with lot numbers 060111, 090111 and 120111. the fda received a report from a hospital that 16 patients had developed colonization or infection with the bacteria pseudomonas aeruginosa. each of these patients was examined with transesophageal ultrasound probes using other-sonic generic ultrasound transmission gel. upon investigation, the ultrasound gel was found to be contaminated with the bacteria pseudomonas aeruginosa and klebsiella oxytoca. regarding the captioned product, the fda recommends healthcare professionals and facilities to: stop using other-sonic generic ultrasound transmission gel from lot numbers 060111 through 120111. identify patients who have been exposed to these lots of other-sonic generic ultrasound transmission gel and review the procedures they underwent and the outcomes of those procedures. for details, please refer to fda website http://www.Fda.Gov/medicaldevices/safety/alertsandnotices/ ucm299409.Htm and http://www.Fda.Gov/safety/medwatch/safetyinformation/ safetyalertsforhumanmedicalproducts/ucm300873.Htm if you are in possession of the product, please contact your supplier for necessary actions.

Device

Other-Sonic Generic Ultrasound Transmission Gel

Manufacturer

Pharmaceutical Innovations