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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSORS SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)
Event Date 09/04/2021
Event Type  Injury  
Event Description
Dexcom g6 left severe burn like marks on arm where it had been applied. Issue was repeated with the next 2 sensors as well. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6 SENSORS
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key12475364
MDR Text Key271930314
Report NumberMW5103952
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 09/13/2021
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received09/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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

Patient Treatment Data
Date Received: 09/14/2021 Patient Sequence Number: 1
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