VENTURA Hydrocephalus Implant Valve 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 manufacturer #121 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    R1709-455
  • 사례 연번
    2015DM-0013522 ; 2015DM-0013521
  • 날짜
    2017-09-27
  • 사례 국가
  • 사례 출처
    INVIMA
  • 사례 출처 URL
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • 데이터 추가 비고

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Valves for hydrocephalus are implant devices used in the surgical treatment of hydrocephalus, to derive the CSF (cerebrospinal fluid) from the ventricles into the peritoneal cavity or to other drainage sites appropriate for a particular patient. Sondispositives produced in medical grade silicones and material-thermoplastic with unrestricted implantability, intended for use in patients with hydrocephalus. The external ventricular drainage catheter with anti-siphon mechanism (CSF "cerebrospinal fluid" / MAS "anti-siphon mechanism") is indicated in temporary relief of intracranial hypertension for any etiology that causes a disturbance in the absorption of the flow of CLL, whether in subarachnoid hemorrhages, interventricular, hydrocephalus, and primary brain tumors. The anti-siphon mechanism has an internal design, which allows the LCR to flow inside without offering additional resistance to the drainage system, and when a negative pressure occurs in the distal part of the system (fall of the bag to the floor, for example), the The anti-siphon mechanism is activated and blocks the sudden emptying of the cerebral ventricles. The external drainage systems are used to drain the cerebrospinal fluid (produced inside the cerebral ventricles) into a collecting container located externally of the human body. These systems are relatively widely used in neurosurgical procedures and, in general, are composed of a
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA