Events

Dycal Radiopaque Calcium Hydroxide Composition Cavity Base/Liner 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 DENTSPLY Caulk 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 사례 연번
    SN2011(19)
  • 날짜
    2011-08-10
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/dycal-radiopaque-calcium-hydroxide-composition-cavity-base-liner&id=d896f825-9782-6eee-9b55-ff00008c97d0
  • 비고 / 경고
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • 데이터 추가 비고
  • 원인
    Dentsply has become aware that certain lots of dycal may exhibit faster setting times than is normal for these products.
  • 조치
    DENTSPLY has been unsuccessful in their attempts to locate all devices affected by this field safety corrective action (FSCA), as one of the distributors in Ireland, O’Neill Dental Ltd., has ceased trading and there are no customer records available to assist traceability.  The IMB advises that users:  • Identify the affected devices in your facility.  • If you have affected devices, follow the manufacturer’s recommendations as outlined in the attached FSN and contact DENTSPLY to arrange for return

Device

Dycal Radiopaque Calcium Hydroxide Composition Cavity Base/Liner
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Dycal Radiopaque Calcium Hydroxide Composition Cavity Base/Liner
  • Manufacturer
    DENTSPLY Caulk

Manufacturer

DENTSPLY Caulk