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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 CGM SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Impaired Healing (2378); Reaction (2414); Caustic/Chemical Burns (2549)
Event Date 09/20/2020
Event Type  Injury  
Event Description
Use dexcom g6 for management of type 1 diabetes. Dexcom changed adhesive formula and i now get a severe reaction, almost like a chemical burn. As being a type 1 diabetic, i heal slower than normal. This did not occur with the prior adhesive formula. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6 CGM
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10958659
MDR Text Key220245804
Report NumberMW5098227
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 12/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
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: 12/04/2020 Patient Sequence Number: 1
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