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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM DEXCOM G5 CONTINUOUS GLUCOSE MONITOR

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DEXCOM DEXCOM G5 CONTINUOUS GLUCOSE MONITOR Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Bruise/Contusion (1754); Pain (1994)
Event Type  Injury  
Event Description
Pain and bruising under insertion site.
 
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Brand NameDEXCOM G5 CONTINUOUS GLUCOSE MONITOR
Type of DeviceDEXCOM G5 CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM
MDR Report Key7568666
MDR Text Key110246211
Report NumberMW5077611
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 06/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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