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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
Model Number G6
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Skin Irritation (2076)
Event Date 06/16/2020
Event Type  Injury  
Event Description
I have been having a reaction to my dexcom g6 for the last 2 months.It leaves raw skin after removal that takes weeks to heal.Allergic reaction.Fda safety report id #: (b)(4).
 
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Brand Name
SENSOR
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC
MDR Report Key10189458
MDR Text Key196467978
Report NumberMW5095185
Device Sequence Number2
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/20/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberG6
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/23/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age60 YR
Patient Weight77
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