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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

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SENSEONICS INC. EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM Back to Search Results
Model Number 102812-81A
Device Problem Difficult to Remove (1528)
Patient Problem Discomfort (2330)
Event Date 06/09/2023
Event Type  Injury  
Manufacturer Narrative
The next removal attempt is scheduled for some time after (b)(6) 2023, and the results of the removal attempt will be provided in the supplemental report.
 
Event Description
On (b)(6) 2023, senseonics was made aware of an adverse event where the physician was unable to remove the sensor from the user's arm on the first attempt due to not being able to remove it cleanly without causing tissue damage and contusion.
 
Manufacturer Narrative
Per case notes, the sensor was successfully removed and the user is doing well after the procedure.B4.Date of this report updated to (b)(6) 2023.G3.Date received by manufacturer updated to (b)(6) 2023.
 
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Brand Name
EVERSENSE SENSOR
Type of Device
EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
Manufacturer (Section D)
SENSEONICS INC.
20451 seneca meadows parkway
germantown MD 20875 7005
Manufacturer (Section G)
SENSEONICS INC.
20451 seneca meadows parkway
germantown MD 20875 7005
Manufacturer Contact
vallikannu somasundaram
20451 seneca meadows parkway
germantown, MD 20875-7005
MDR Report Key17250999
MDR Text Key318346705
Report Number3009862700-2023-00142
Device Sequence Number1
Product Code QHJ
UDI-Device Identifier00817491022974
UDI-Public817491022974
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P160048
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date02/17/2023
Device Model Number102812-81A
Device Catalogue NumberFG-7202-00-301
Device Lot NumberWP08816
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/09/2023
Initial Date FDA Received07/03/2023
Supplement Dates Manufacturer Received07/24/2023
Supplement Dates FDA Received09/27/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/14/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age23 YR
Patient SexMale
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