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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 TRANSMITTER ADHESIVE SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Rash (2033); Burning Sensation (2146)
Event Date 09/01/2020
Event Type  Injury  
Event Description
Itchiness; dexcom g6 adhesive causes burning, rash, blisters. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 TRANSMITTER ADHESIVE
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10493659
MDR Text Key205906891
Report NumberMW5096424
Device Sequence Number1
Product Code MDS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG6
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: 09/03/2020 Patient Sequence Number: 1
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