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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 CGM SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Caustic/Chemical Burns (2549)
Event Date 09/09/2020
Event Type  Injury  
Event Description
Experienced chemical burns from dexcom g6 adhesive pads. Skin under the adhesive pad began itching, then discharging yellow liquid, then bleeding. Had to remove dexcom g6 device prior to 10 day indicated wear period. Fda safety report id# (b)(4).
 
Event Description
Additional info received from reporter on 12/30/2020 for mw5098608. Experienced chemical burns from dexcom g6 adhesive pads. Skin under the adhesive pad began itching, then discharging yellow liquid, then bleeding. Had to remove dexcom g6 device prior to 10 day indicated wear period. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 CGM
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11100706
MDR Text Key224810763
Report NumberMW5098608
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 12/30/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG6
Device Lot Number5279384
Was Device Available for Evaluation? No
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: 12/31/2020 Patient Sequence Number: 1
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