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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 7279435
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Superficial (First Degree) Burn (2685); Skin Inflammation/ Irritation (4545)
Event Date 06/24/2021
Event Type  Injury  
Event Description
A skin reaction occurred 5 days after installing a dexcom g6 sensor on my upper arm. Resembles a burn. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6 SENSOR
Type of Device SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key12107365
MDR Text Key260058247
Report NumberMW5102248
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 06/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number7279435
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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