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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM 6 SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number DEXCOM 6 SENSOR
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Rash (2033)
Event Date 10/01/2020
Event Type  Injury  
Event Description
Causes rash and itching; i wear a dexcom 6 and apparently there were patients who had a problems with itching and severe rash. So dexcom changed the adhesive. Well now that they changed the adhesive i now have the itch and rash. They need to fix this crap. Fda safety report id# (b)(4).
 
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Brand NameDEXCOM 6
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11265552
MDR Text Key230056260
Report NumberMW5099133
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 01/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/19/2021
Device Model NumberDEXCOM 6 SENSOR
Device Lot Number5279889
Was Device Available for Evaluation? Yes
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: 02/01/2021 Patient Sequence Number: 1
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