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

Model Number	103606-610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Impaired Healing (2378); Fluid Discharge (2686)
Date of Event	05/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, senseonics was made aware of a user experiencing prolonged wound closure.The steri-strips were removed on (b)(6) 2026, after which the user observed drainage, redness, and pain at the site, although the sensor was not visible in the incision.The user's healthcare provider was not aware of the issue, and the user was advised to follow up for further medical evaluation.Despite the symptoms, the data management system confirmed the system remains in use with up-to-date data.As a result of the event, the user requested the sensor be removed.
Additional Manufacturer Narrative
Delayed wound healing is a known and anticipated potential adverse effect as described in the eversense user guide, which does not require additional investigation.

• Brand Name: EVERSENSE SENSOR
• Common Device Name: 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 samasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 25526991
• Report Number: 3009862700-2026-02066
• Device Sequence Number: 17529325
• Product Code: SBA
• UDI-Device Identifier: 00817491024299
• UDI-Public: 817491024299
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P160048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: 103606-610
• Device Catalogue Number: FG-7501-00-301
• Device Lot Number: 01G083S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Supplement Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 06/16/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Unknown