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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
Lot Number 52754340
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Rash (2033); Scarring (2061); Caustic/Chemical Burns (2549)
Event Date 07/27/2020
Event Type  Injury  
Event Description
Skin burns / open wound; dexcom changed the adhesive on their g6 diabetes sensors. The new adhesive causes skin rashes/burns and leaves scarring that lasts for weeks. Also, the sensors are supposed to be on for 10 days- but skin can't stand it. Sensors are roughly $(b)(6)/each, so people are losing a ton of money. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10454065
MDR Text Key204625565
Report NumberMW5096279
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 Patient
Type of Report Initial
Report Date 08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/18/2021
Device Lot Number52754340
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: 08/25/2020 Patient Sequence Number: 1
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