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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
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Rash (2033); Superficial (First Degree) Burn (2685)
Event Date 06/10/2021
Event Type  Injury  
Event Description
After using dexcom 6 twice, a horrible painful rash/burn formed that still has not gone away after two weeks.Fda safety report id # (b)(4).
 
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Brand Name
DEXCOM 6
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key12106957
MDR Text Key260029601
Report NumberMW5102237
Device Sequence Number1
Product Code MDS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/27/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received07/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age41 YR
Patient Weight58
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