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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSOR ADHESIVE SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Scarring (2061); Skin Irritation (2076); Swelling (2091); Burning Sensation (2146); Impaired Healing (2378)
Event Date 05/25/2020
Event Type  Injury  
Event Description
Reporter said she has been experiencing burning, itching, high raised bumps, scarring, very red and warm skin from the sensor's adhesive. She also said it takes forever to heal. She said she did not have this problem using dexcom g6 sensors 5 months ago. She said she contacted the manufacturer for replacement since they don't last as long as they are supposed to.
 
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Brand NameDEXCOM G6 SENSOR ADHESIVE
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10514427
MDR Text Key206555220
Report NumberMW5096526
Device Sequence Number5
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 09/09/2020
5 Devices were Involved in the Event: 1   2   3   4   5  
0 Patients were Involved in the Event:
Date FDA Received09/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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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