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U.S. Department of Health and Human Services

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

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DEXCOM, INC. G6 CGM SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problems Device Ingredient or Reagent Problem (2910); Patient Device Interaction Problem (4001)
Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033)
Event Date 04/15/2021
Event Type  Injury  
Event Description
Red, itching, long-lasting rash due to dexcom g6 adhesive change. Fda safety report id # (b)(4).
 
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Brand NameG6 CGM
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11731498
MDR Text Key247705453
Report NumberMW5100989
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 04/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2021
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

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