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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G6 SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number 5294748
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Caustic/Chemical Burns (2549); Fluid Discharge (2686)
Event Date 05/19/2022
Event Type  Injury  
Event Description
Chemical burns on skin; i had severe itching under my dexcom g6 sensor prior to the 10-day wear time. Upon removal, i noticed a red, raised, oozing rash that covered nearly the entire area of the sensor adhesive. Dexcom was called for a replacement sensor and was only accommodating after agreeing with them. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key14513892
MDR Text Key292964349
Report NumberMW5109922
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Lot Number5294748
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 05/25/2022 Patient Sequence Number: 1
Treatment
DEXCOM G6 ; HUMALOG INSULIN ; LEVOTHYROXINE ; LISINOPRIL ; MEDTRONIC 670G INSULIN PUMP ; PROVENTIL HFA; VITAMIN C ; ZINC
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