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U.S. Department of Health and Human Services

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

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DEXCOM, INC. SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Erythema (1840); Itching Sensation (1943); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Event Date 10/02/2021
Event Type  Injury  
Event Description
Swelling; i have been wearing a dexcom g6 since january without a problem. Over the past two months, i have been having redness, itching, irritation and erythema at the site of insertion. Fda safety report id # (b)(4).
 
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Brand NameSENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key12583833
MDR Text Key275272658
Report NumberMW5104429
Device Sequence Number2
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 10/03/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/05/2021
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 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: 10/05/2021 Patient Sequence Number: 1
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