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Model Number N/A |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
Urinary Tract Infection (2120)
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Event Type
Injury
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Manufacturer Narrative
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We have no additional information at this time.We have made multiple attempts to contact the reporter and attain more information about this case.(b)(4).Please find the original submission (26jan2017) from the test account.
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Event Description
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Voluntary report was submitted to the fda on 19dec2016: notified of recent hospitalization via insurance claims.Diagnosis for admission n39.) uti site not specified, admit date 2016, discharge date 2016, dose or amount:30 mg, frequency: weekly for 3 wks, route 1a, dates of use: 2016, diagnosis of reason for use m17.0.Anika was informed about this event via letter from the fda received 09jan2017.This letter references report number mw5066764.Anika has made various documented attempts to attain additional information on this case without success.At this time there is no new information to report.Should any new information be received we will submit accordingly.
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Manufacturer Narrative
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We have no additional information at this time.We have made multiple attempts to contact the reporter and attain more information about this case.This report was originally filed on 03feb2017 on the test server.The account was recently moved to the production server on 7august2017.I was informed to resubmit all previous files to the production server.Production account approval help desk ticket #(b)(4).Notification of moving files to production account help desk ticket #(b)(4).
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Event Description
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Voluntary report was submitted to the fda on 19dec2016: notified of recent hospitalization via insurance claims.Diagnosis for admission n39.) uti site not specified, admit date 2016, discharge date 2016, dose or amount:30 mg, frequency: weekly for 3 wks, route 1a, dates of use: 2016, diagnosis of reason for use m17.0 anika was informed about this event via letter from the fda received 09jan2017.This letter references report number mw5066764.Anika has made various documented attempts to attain additional information on this case without success.At this time there is no new information to report.Should any new information be received we will submit accordingly.
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Search Alerts/Recalls
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