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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Urticaria (2278); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/02/2020
Event Type  Injury  
Event Description
The adhesive that connects my dexcom g6 sensor to my skin causes hives, scarring, and intense itching. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 CONTINUOUS GLUCOSE MONITOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11472899
MDR Text Key239749749
Report NumberMW5099971
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 03/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2021
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

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