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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM 6 SENSOR SENSOR, GLUCOSE, INVASIVE

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DEXCOM, INC. DEXCOM 6 SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number 5290536
Device Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033)
Event Date 10/27/2021
Event Type  Injury  
Event Description
Using dexcom 6 sensors after being applied start to itch day 2, at day ten when removed left with raised, red itchy rash which can last for a month or longer. Seems to be like a yeast rash. Entered one lot number, but has happened with all i've used. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM 6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key12728316
MDR Text Key279569655
Report NumberMW5105039
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 10/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2022
Device Lot Number5290536
Was Device Available for Evaluation? No
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

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