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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
Model Number G6
Device Problem Difficult to Remove (1528)
Patient Problems Blister (4537); Skin Inflammation/ Irritation (4545)
Event Date 01/31/2021
Event Type  Injury  
Event Description
Dexcom sensor tape has changed.It's like they're now using super glue.I've used dexcom for 8 years and have never had this issue until now.The glue is so strong, i have difficulty removing the tape at the end of 10 days.It takes a layer of skin off leaving welts and blood blisters after it's removed.I've never experienced this before.Fda safety report id# (b)(4).
 
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Brand Name
DEXCOM G6
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11278711
MDR Text Key230477836
Report NumberMW5099210
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/10/2021
Device Model NumberG6
Device Lot Number7277598
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/03/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age69 YR
Patient Weight79
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