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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number 7289531
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Skin Inflammation/ Irritation (4545)
Event Date 05/22/2021
Event Type  Injury  
Event Description
Applying the dexcom g6 adhesive directly to my skin always leaves a moderate rash / allergic reaction upon taking it off after the 10-day expiration. During the 10-day period, it becomes increasingly itchy and irritated underneath, and upon removing the adhesive, it becomes visibly redder and irritated with bumps. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6 CONTINUOUS GLUCOSE MONITORING SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11885111
MDR Text Key252967328
Report NumberMW5101538
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 05/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number7289531
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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