spine supports and lower limb orthosis 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Össur Inc || Ossur HF 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
    I1603-131
  • 사례 연번
    2014DM-0011389 ; 2014DM-0011021
  • 날짜
    2016-03-31
  • 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
  • 원인
    The manufacturer reports that it has detected that the referenced products contain components with natural rubber latex not declared in the product, leading to the potential occurrence of adverse events in latex patients.

Device

  • 모델명 / 제조번호(시리얼번호)
    COLLAR MIAMI J; UNDERSLEEVE, REBOUND and UNLODER, specific product numbers || respectively.
  • 제품 설명
    Advanced stabilization devices for the spine and cervical area. Designed to meet the specific requirements of the patient and the doctor .---- In the immobilization in trauma, general post-surgery, dislocations, to immobilize the lower limb, pre or post-surgical immobilization of lesions of the soft tissues, use in trauma and rehabilitation, postoperative stabilization of the ankle, stable fractures, detobillo sprain of grade 2 and 3. In collateral stabilization of the articulation in moderate instabilities, helps in moderate injuries of the lateral ligaments, demenis lesions, preventing hyperexpression, in instability of the medial and lateral ligaments , in minor or moderate joint stability, articulatory protection against the remissions of sprains when resuming sports activity. In the postoperative period in which some immobilization and gradual increase in movement, tendon injuries, fractures or dislocations of the tibiotarsal joint are required, conservative management of the Metatarsus and tarsus, functional therapy of Achilles tendon rupture, chronic ligament instabilities.
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    NIDFSINVIMA