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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
Catalog Number STS-OR-003
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Fluid Discharge (2686); Blister (4537)
Event Date 11/23/2020
Event Type  Injury  
Event Description
I was using my dexcom g6 sensor for my cgm system, which i had been using for months. After a day or two of insertion i began having itchy, weeping blisters under the site. I had to find a barrier method to help prevent the adhesive from touching my skin, and until i found one that worked they have left scars. 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 Key11272512
MDR Text Key230317647
Report NumberMW5099164
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 01/30/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/22/2021
Device Catalogue NumberSTS-OR-003
Device Lot Number7279817
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

Patient Treatment Data
Date Received: 02/02/2021 Patient Sequence Number: 1
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