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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINOUS GLUCOSE MONITOR

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINOUS GLUCOSE MONITOR Back to Search Results
Model Number 9500-27
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Itching Sensation (1943); Rash (2033); Skin Irritation (2076); Wheal(s) (2241)
Event Date 12/07/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Labeling indicates: inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain or skin irritations (e. G. ,redness, swelling, bruising, itching, scarring or skin discoloration).
 
Event Description
Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2016, the patient experienced a skin reaction. The sensor was inserted into the upper buttocks on (b)(6) 2016. The reaction was located on the right side of the upper buttocks where the insertion was done. The reaction was described as a skin irritation with itching and a rash coming out just a little passed the adhesion. On (b)(6) 2016, upon removal of the sensor pod puss was seen at the insertion site, in addition to hives all around the adhesion. The affected area was treated with over the counter (otc) neosporin, benadryl spray and bandages. The patient's mother took the patient to the doctor to get help with the rashes. Date of medical intervention is unknown, along with details of the intervention. At the time of contact, the patient was ok. No additional event or patient information was provided.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer (Section G)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key6455628
MDR Text Key71575908
Report Number3004753838-2017-26275
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 03/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/03/2017 Patient Sequence Number: 1
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