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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSOR; SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Purulent Discharge (1812); Erythema (1840); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)
Event Date 06/22/2021
Event Type  malfunction  
Event Description
Skin reaction to dexcom g6 - first time i've had a reaction.Itched very bad - had to remove after 2 days.Skin is red, irritated and still itches.When i removed it - there was blood/puss around were the sensor goes into my skin.Fda safety report id# (b)(4).
 
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Brand Name
DEXCOM G6 SENSOR
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key12086980
MDR Text Key259174343
Report NumberMW5102189
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 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age50 YR
Patient Weight68
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