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MAUDE Adverse Event Report: ALERE INR MONITOR
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ALERE INR MONITOR
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Device Problem
Use of Device Problem (1670)
Patient Problem
No Consequences Or Impact To Patient (2199)
Event Type
No Answer Provided
Event Description
Nothing happened, there was no event.
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Submit an Adverse Event Report
Brand Name
INR MONITOR
Type of Device
INR MONITOR
Manufacturer
(Section D)
ALERE
*
MDR Report Key
4628104
MDR Text Key
15139672
Report Number
MW5041601
Device Sequence Number
1
Product Code
GJS
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
Voluntary
Reporter Occupation
Other
Type of Report
Initial
Report Date
03/18/2015
1
Device was Involved in the Event
1
Patient was Involved in the Event
Is this an Adverse Event Report?
No
Is this a Product Problem Report?
No
Device Operator
Other
Was the Report Sent to FDA?
No
Initial Date Manufacturer Received
Not provided
Initial Date FDA Received
03/18/2015
Patient Sequence Number
1
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