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

Model Number 102096-67A

Device Problem No Apparent Adverse Event (3189)

Patient Problem Wound Dehiscence (1154)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

Prolonged wound healing of incision after insertion or removal.

Event Description

On (b)(4) 2019, senseonics was made aware of a prolonged wound healing event.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING 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: sachin thanawala ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 9266375
• MDR Text Key: 164615047
• Report Number: 3009862700-2019-00279
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491022349
• UDI-Public: 00817491022349
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2019

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 Date: 03/04/2020
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP06190
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 11/01/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR