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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM'S G6 DEVICE SENSOR, GLUCOSE, INVASIVE

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DEXCOM, INC. DEXCOM'S G6 DEVICE SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Skin Disorders (4543)
Event Date 01/12/2022
Event Type  Injury  
Event Description
Skin reaction to dexcom g6 adhesive. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM'S G6 DEVICE
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key13425148
MDR Text Key285014309
Report NumberMW5107138
Device Sequence Number1
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 Unknown
Type of Report Initial
Report Date 01/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

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