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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 Device Ingredient or Reagent Problem (2910)
Patient Problem Caustic/Chemical Burns (2549)
Event Date 05/10/2021
Event Type  Injury  
Event Description
The dexcom g6 sensor leaves a chemical burn every time i use one. They changed adhesives and it has been happening since which includes my arm, stomach and leg. 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 Key11847840
MDR Text Key251675000
Report NumberMW5101404
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 05/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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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