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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Inflammation (1932); Itching Sensation (1943); Skin Irritation (2076)
Event Date 07/17/2020
Event Type  Injury  
Event Description
Used dexcom g6 sensor that was equipped with their new adhesive formula. The product is intended to wear on body for 10 days. By day 3, the skin under the adhesive was itching uncontrollably to the point i had to remove it from my body. I was left with inflamed red irritated skin with open tears in the skin. Inflammation, redness, and scabbing lasted for 2 weeks. 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 Key11272611
MDR Text Key230316683
Report NumberMW5099170
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
1 Device was Involved in the Event
0 Patients were 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 Model NumberG6
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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