Events

Alerte De Sécurité sur Commercial Name: Ureteric Illuminating Catheters Bush Technical Name: Catheters ANVISA Registration Number: 10330710065 Hazard Class: II Affected Model: 084120 and J-BICS-058020 Affected Lot / Serial Numbers: U2412468; U2412469; U2412470; U2413367; U2413911; U2429088; U2452670; 4,946,704; 4,965,697; 4,976,258; 4999997; 4,999,998; 5003247; 5007047; 4942636; 5,138,605; 5,141,718; 5,141,199; 5,145,105; 5,149,622; 5,149,623; 5,365,572; 5,365,642; 5,370,995; 5,388,926; 5509391; 5,518,548; 5,518,549; 5,593,065; 5,684,248; 5,718,485; 5,721,755; 5,737,801; 5,744,000; 5744001; 5,743,999; 5,766,046; 5,766,047; 5,789,746; 5794877; 5,798,213; 5,826,962; 5,973,018; 6008488; 5,978,226; 6008489; 6,056,601; 6073730; 6073731; 6127074; 6131751; 6131752; 6,142,020; 6,142,021; 6146513; 6146514; 6146518; 6228742; 6,242,198; 6371295; 6,375,171; 6,396,897; 6,396,898; 6214087; 6,247,244; 6255677; 6,262,720; 6,295,798; 6653171; 6719828; 6,519,829; 6,262,338; 6,360,647; 6,360,648; 6364334; 6371297; 6371298; 6,998,469; 7,012,893; 7,016,375; 7,016,376; 7,128,835; 7,134,480; 7162449; 7162450; 7162451; 7457006

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Handle Comércio de Equipamentos Médicos Ltda; Cook Incorporated.

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
  • ID de l'événement
    2245
  • Date
    2017-03-23
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    If direct skin or patient contact with overheated devices resulting in skin damage, including burns, it is recommended to seek medical attention.
  • Cause
    The cook medical group initiated voluntary recall of bush ureter illuminating catheters (references 084120 and j-bics-05802) due to the increased number of complaints that the black conductor in the proximal portion, which connects to the transparent component of the bush ureteral illumination catheter , it can overheat and melt. there have been no reports of overheating along the transparent component of the catheter, which is the part of the device that comes in contact with the patient's urethra, bladder, and ureter.
  • Action
    Field Action Code No.207 / RNC 031 - 032 / RA 018 triggered under the responsibility of Handle Comércio de Equipamentos Médicos Ltda. Company will collect.

Device

Commercial Name: Ureteric Illuminating Catheters Bush Technical Name: Catheters ANVISA Registrati...

Manufacturer

Handle Comércio de Equipamentos Médicos Ltda; Cook Incorporated
  • Source
    ANVSANVISA