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U.S. Department of Health and Human Services

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

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DEXCOM, INC. G6 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Device Ingredient or Reagent Problem (2910)
Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Disorders (4543)
Event Date 09/12/2020
Event Type  Injury  
Event Description
I use a dexcom g6 to manage my blood sugar and base my insulin intake with my pump on the cgm's readings. There has recently been a new ingredient put in the adhesive of the g6 and i am having terrible allergic skin reactions. Fda safety report id# (b)(4).
 
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Brand NameG6
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10829199
MDR Text Key216184988
Report NumberMW5097791
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 11/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
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

Patient Treatment Data
Date Received: 11/10/2020 Patient Sequence Number: 1
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