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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Product Quality Problem (1506)
Patient Problems Inflammation (1932); Itching Sensation (1943); Reaction (2414)
Event Date 08/01/2020
Event Type  Injury  
Event Description
Reporter stated that he has been wearing the dexcom g6 sensor for over three years. Recently he started having problems with the adhesive on the sensor. He stated the entire area where the sensor is placed is inflamed, itchy and it takes about two weeks for it to heal. He further reported that the sensor supposed to last ten days but because of the itching it barely last three days. Reporter stated that he is allergic to the adhesive on the sensor.
 
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Brand NameDEXCOM G6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10436897
MDR Text Key204190182
Report NumberMW5096186
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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: 08/20/2020 Patient Sequence Number: 1
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