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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 101967-950
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Swelling/ Edema (4577)
Event Date 09/27/2023
Event Type  Injury  
Event Description
Senseonics was made aware of an incident where the patient reported swelling, bruising and pain at the insertion site.The symptoms first began on (b)(6) 2023.The patient stated that they were using a grip band to place the transmitter over the sensor.The patient did not specify the reason for using grip band.The patient visited hcp who advised to remove the sensor and insert another sensor in the other arm.
 
Manufacturer Narrative
This mdr is a result of retrospective review of complaints.A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.The sensor is inserted by making a small incision and placing it under skin and potential for developing skin irritation/swelling/pain/ inflammation/infection around the insertion site is a known anticipated adverse event.The symptoms were first observed on (b)(6) 2023 and the patient consulted hcp.No medication was prescribed to treat the affected area.The hcp advised to have the sensor removed and insert another one in the other arm.No further updates could be gathered due to lack of response from the patient.There is no remedial action/corrective action/preventive action/field safety corrective action required.
 
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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 20876 7005
Manufacturer (Section G)
SENSEONICS INC.
20451 seneca meadows parkway
germantown MD 20876 7005
Manufacturer Contact
vallikannu somasundaram
20451 seneca meadows parkway
germantown, MD 20876-7005
MDR Report Key18252860
MDR Text Key329551163
Report Number3009862700-2023-00314
Device Sequence Number1
Product Code QHJ
UDI-Device Identifier00817491023308
UDI-Public817491023308
Combination Product (y/n)Y
Reporter Country CodeGM
PMA/PMN Number
P160048
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 12/01/2023
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 Date11/24/2023
Device Model Number101967-950
Device Catalogue NumberFG-4500-50-302
Device Lot NumberWP09143
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/05/2023
Initial Date FDA Received12/01/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/28/2022
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;
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