Events

GYNECARE MORCELLEX FABRIC LAYER - Models MX0100, MX0100R - Register 80145901131 and GYNECARE X-TRACT LAPAROSCOPY FRAGMENTER - Models MD0100, DV0015, MD0120 - Record 10132590592 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda 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
    1384
  • 날짜
    2014-05-06
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    The company reports in the general population, the use of tissue morbidity has been associated with collateral injuries such as small, broad vascular structures of the bladder, ureter, kidney and diaphragm. These complications only occur under special circumstances, since, according to the surgeon's instructions, the tissue must be completely exposed before application of the device, according to instructions for use. The reevaluation of epidemiological data leads us to conclude that the rate of probability of sarcoma in a population submitted to hysterectomy for a benign indication can be as high as 0.2%. Therefore, the probability of death, permanent disability and / or need for surgical intervention is higher, that is, it is an event for which the result of injury is expected, but only occasionally. According to the FDA, electrical morbidity may still be the best therapeutic option for some patients after a cautious evaluation of benefit-risk and signing of the informed consent term.
  • 원인
    Johnson & johnson do brasil ind. and com. de prod. for health ltda has issued a safety alert on gynecare morcellex tissue morcorator products and gynecare x-tract laparoscopy fragmenter, stating that until recently, women were commonly advised of the risk of malignancy in a myoma that is 1 in 10,000. [hampton t. 2014]. this rate is currently under debate. in order to align with the fda's recent safety communication we have decided to suspend the marketing of our morcellating products while the role of morcelation for patients with symptomatic fibrotic diseases is redefined by the fda and the medical community. in light of the fda's april 17 public communication discouraging the use of morcelation during hysterectomies or laparoscopic myomectomies, we believe that suspending the marketing of these products until their role is better understood and redefined by the medical community is the appropriate course of action in this time. it is important to note that ethicon morcelling devices have always included care in their instructions for use (ifu) on the possible spread of malignant (or suspected malignant) tissue. also, please note that we are not removing the product on the market at this time.
  • 조치
    The company directs that the customer who owns the product should only distribute this notification to all users of the Ethicon Moratorium Devices at their facility. Because this decision is not related to safety or efficacy, it is not necessary for customers who own these products to take any action such as returning or stopping the product. See Annexes: Distribution List (Annex I) and Letter to the Client (Annex II).

Device

GYNECARE MORCELLEX FABRIC LAYER - Models MX0100, MX0100R - Register 80145901131 and GYNECARE X-TR...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda