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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM INC DEXCOM G6 SENSOR, GLUCOSE, INVASIVE

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DEXCOM INC DEXCOM G6 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number DEXCOM G6
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Caustic/Chemical Burns (2549)
Event Date 12/08/2020
Event Type  Injury  
Event Description
Using dexcom, the sensor pad and/or adhesive on the pad caused an oval shape irritation/burn on my skin. Third time it has happened. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM INC
MDR Report Key10991792
MDR Text Key221287190
Report NumberMW5098319
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/09/2020
3 Devices were Involved in the Event: 1   2   3  
0 Patients were Involved in the Event:
Date FDA Received12/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDEXCOM G6
Was Device Available for Evaluation? Yes
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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