ShoulderFlex massager 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 N/A 에 의해 제조된 제품과 관련되어 있습니다.

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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
  • 날짜
    2011-08-26
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Press release
  • 원인
    Safety alert on shoulderflex massager after assessing a medical device safety alert issued by the us food and drug administration (fda) on a personal massager with the brand name “shoulderflex” distributed in the us by a company called king international, the department of health (dh) urges the local community to stop using it because of its association with strangulation or other severe injuries. a dh spokesman remarks that the shoulderflex massager is designed for home use to provide deep tissue massage to the neck, shoulder and back while the user lies on a flat surface. "through the department's medical device surveillance scheme, we learnt that there were a few reports of either death or near-strangulation associated with shoulderflex massager in the us.  according to the information available, the incidents were likely to occur when hair, clothing or jewelry became caught in the device, especially those pieces which rotated during use," the spokesman explains. the spokesman states that the department is very concerned as the health risks could be serious even if not fatal.   "thus, in spite of the facts that the devices were mainly sold at stores or online in the us and not known to be on sale here in hong kong, nor has dh received any related notification, given the amount of travelling between the two places and also the popularity of internet trading, we consider it necessary to inform our public of the news and also advise for immediate suspension for the occasional owners," the spokesman deliberates. finally, the spokesman adds that to be prudent, disposal of the device by owners should be in pieces so as to avoid use after reassembling. ends.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 제품 설명
    Press release: Safety alert on ShoulderFlex massager
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    DH