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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Itching Sensation (1943); Superficial (First Degree) Burn (2685)
Event Date 03/01/2021
Event Type  Injury  
Event Description
I wear dexcom 6 sensor and after a couple days on my stomach it starts to itch pretty bad. By the time 10 days are up, when it's time to change the adhesive has pretty much burned a circle the size of the patch that is completely red and raw. Kinda like an open wound. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11495305
MDR Text Key240404408
Report NumberMW5100008
Device Sequence Number1
Product Code MDS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/01/2021
Device Model NumberG6
Device Catalogue NumberSTS OM 003
Device Lot Number5281851
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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