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MedicalDevice版 - 怎样在FDA网站查一个产品的负面事件 - MAUDE
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1 (共1页)
a*i
发帖数: 1652
1
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/searc
MAUDE data represents reports of adverse events involving medical devices.
The data consists of voluntary reports since June 1993, user facility
reports since 1991, distributor reports since 1993, and manufacturer reports
since August 1996. MAUDE may not include reports made according to
exemptions, variances, or alternative reporting requirements granted under
21 CFR 803.19.
The on-line search allows you to search CDRH database information on medical
devices which may have malfunctioned or caused a death or serious injury.
MAUDE is scheduled to be updated monthly and the search page reflects the
date of the most recent update. FDA seeks to include all reports received
prior to the update. However, the inclusion of some reports may be delayed
by technical or clerical difficulties.
MAUDE data is not intended to be used either to evaluate rates of adverse
events or to compare adverse event occurrence rates across devices. Please
be aware that reports regarding device trade names may have been submitted
under different manufacturer names. Searches only retrieve records that
contain the search term(s) provided by the requester.
h********e
发帖数: 2823
2
真不错啊,可以当板斧啦!
多几个版务在线我好骗包子啊 :)

reports
medical

【在 a*i 的大作中提到】
: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/searc
: MAUDE data represents reports of adverse events involving medical devices.
: The data consists of voluntary reports since June 1993, user facility
: reports since 1991, distributor reports since 1993, and manufacturer reports
: since August 1996. MAUDE may not include reports made according to
: exemptions, variances, or alternative reporting requirements granted under
: 21 CFR 803.19.
: The on-line search allows you to search CDRH database information on medical
: devices which may have malfunctioned or caused a death or serious injury.
: MAUDE is scheduled to be updated monthly and the search page reflects the

1 (共1页)
进入MedicalDevice版参与讨论
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