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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 SENSOR, GLUCOSE, INVASIVE

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DEXCOM, INC. DEXCOM G5 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Rash (2033); Discharge (2225); Impaired Healing (2378)
Event Date 08/04/2020
Event Type  Injury  
Event Description
Have used the g5 and the g6 for a long time with zero reaction to my skin but they have changed the adhesive, and it now produces a severe chemical like burning rash that itches honorably and causes oozing welts that take weeks to heal. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G5
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10419785
MDR Text Key203489335
Report NumberMW5096102
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 08/14/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/17/2020
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
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: 08/17/2020 Patient Sequence Number: 1
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