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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 Erythema (1840); Itching Sensation (1943); Rash (2033); Skin Discoloration (2074); Burning Sensation (2146); Skin Disorders (4543)
Event Date 01/04/2022
Event Type  Injury  
Event Description
Dexcom g6 cgm frequently causes significant skin irritation (including redness, rashes, weeping, bleeding bumps, itchiness, and burning). This has happened despite proper/recommended application. It has also happened with attempts at using additional application procedures (ex: flonase, barrier films). This has happened on numerous occasions, on different body parts. 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 Key13196054
MDR Text Key283499302
Report NumberMW5106515
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 01/06/2022 Patient Sequence Number: 1
Treatment
CGM; LONG ASKING INSULIN; SHORT ACTING INSULIN
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