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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM SENSOR (ADHESIVE) SENSOR, GLUCOSE, INVASIVE

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DEXCOM, INC. DEXCOM SENSOR (ADHESIVE) SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Irritation (2076); Swelling (2091); Reaction (2414)
Event Date 08/28/2020
Event Type  Injury  
Event Description
New versions (tried both new versions) of dexcom sensor adhesive causes a severe skin reaction where the skin blisters and peels. Previous version is not available per dexcom customer service. Please ask the dexcom to switch back to the previous version of the adhesive. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM SENSOR (ADHESIVE)
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key10482221
MDR Text Key205509125
Report NumberMW5096369
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 Pharmacist
Type of Report Initial
Report Date 08/28/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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: 09/01/2020 Patient Sequence Number: 1
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