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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM G4 CONTINUOUS GLUCOSE MONITOR

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DEXCOM G4 CONTINUOUS GLUCOSE MONITOR Back to Search Results
Model Number 9500-26
Device Problem Insufficient Information (3190)
Patient Problems Rash (2033); Discharge (2225); Impaired Healing (2378); Reaction (2414)
Event Type  Injury  
Event Description
Type 1 diabetic child uses dexcom g4. Adhesive from device leaves rash/wound that oozes and will not heal without prescription strength steriod we obtained from her pediatrician. She has been using this device for over a year and has been having this extreme reaction for the last 6 months.
 
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Brand NameG4 CONTINUOUS GLUCOSE MONITOR
Type of DeviceG4 CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM
MDR Report Key5347261
MDR Text Key35242321
Report NumberMW5058894
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 01/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date08/08/2016
Device Model Number9500-26
Device Lot Number5203002
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/03/2016 Patient Sequence Number: 1
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