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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Rash (2033); Skin Tears (2516); Skin Inflammation/ Irritation (4545)
Event Date 10/01/2019
Event Type  Injury  
Event Description
Rashes developed to dexcom adhesive. This did not happen until around this time. Had been using dexcom for about 3 years prior with no issue. Rashes itch, raised red bumps. Skin damages after turning very scaled. No other product is used on skin prior to application. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM G6
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11332401
MDR Text Key232220137
Report NumberMW5099390
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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

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