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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
Lot Number 7276816
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Rash (2033); Fluid Discharge (2686); Blister (4537)
Event Date 01/22/2021
Event Type  Injury  
Event Description
Last year dexcom changed the adhesive on the dexcom g6 sensor a constant glucose monitor, it is now producing a severe rash, blisters, and weeping under the adhesive. I called dexcom to report the problem, and i was told that the new adhesive was tested for skin sensitivity; therefore, i should not have a problem. I don't think they were even listening. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM INC.
MDR Report Key11228919
MDR Text Key228899812
Report NumberMW5098986
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Lot Number7276816
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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