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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 Interaction Problem (4001)
Patient Problems Abrasion (1689); Erythema (1840); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Itching Sensation (1943); Pain (1994); Scarring (2061); Skin Burning Sensation (4540)
Event Date 11/07/2020
Event Type  Injury  
Event Description
I started the dexcom g6 sensor about two months ago. My first one, i lasted 7 days before itching started. I had to remove on either the 8th or 9th day of the 10-day sensor before it got so painful that i had to remove it. My skin under the adhesive peel was bright red, raised and bumpy, itchy, burning and some parts were so raw i was bleeding. I treated with antibiotic cream and lotion and today, i have a gray/brown ovular scar where that site was. About six days ago i said let me try again because the first time i used a barrier adhesive for it to stick better, so i thought it was that. I didn't use the adhesive this time. On saturday the 7th, i had to remove due to the unbearable itching again. This time, i had all the same symptoms (bumps, burning, raw skin) in a perfect oval, but also a new symptom: the sticky part of the transmitter (what comes on the actual site you inject) had a yellow fluid spotted on it, indicating infection of the open wound. I have been treating with antibiotic cream and keeping the area clean and dry by washing every six hours and redoing my dressing. I am sure this will scar as well. It is embarrassing and i just moved to (b)(6) from (b)(6) to enjoy the beach and weather with my fiancé, and now i cannot wear a bikini or crop top because of my embarrassing bright red infected abdomen. This is making me tear up as i write this. Please look into this. Dexcom transferred me back and forth between technical support and customer service- technical gave me their own url link to their "sensitive skin" page, and service told me to contact my doctor because "i must be allergic. " there are forums on diabetic blogs and (b)(6) about others who have suffered adverse reactions to the dexcom g6, ranging from mild itching to permanent scars (including me). Please help. 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 Key10836638
MDR Text Key216338639
Report NumberMW5097834
Device Sequence Number2
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 11/09/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
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: 11/12/2020 Patient Sequence Number: 1
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