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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM CGM G6 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Scarring (2061); Skin Irritation (2076)
Event Date 10/22/2020
Event Type  Injury  
Event Description
Complete allergic reaction to the adhesive dexcom now uses for their g6 sensors. Damaged skin, terrible itchiness. Scarred for weeks. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM CGM G6
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10733253
MDR Text Key213467742
Report NumberMW5097439
Device Sequence Number1
Product Code MDS
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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: 10/23/2020 Patient Sequence Number: 1
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