MAUDE Adverse Event Report: SENSEONICS INCORPORATED EVERSENSE SENSOR; CONTINUOUS GLUCOSE MONITOR

Model Number 102096-67A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 04/29/2019

Event Type  Injury  

Manufacturer Narrative

The user's healthcare professional made a large incision for the sensor removal measuring 15mm resulting in a large wound.The user received two stitches after the removal procedure but the wound was not fully closed which resulted in excessive bleeding after the procedure.As a result, the user received medical attention at the emergency room.The emergency room medical professionals closed the incision site with dermabond, larger steri-strips and the user received a tetanus shot.As of (b)(6) 2019, the user reported that the post-removal procedure stitches and the steri-strips were out, the bleeding had stopped and he was doing well.

Event Description

On (b)(6) 2019 senseonics was made aware of an adverse event where the user experienced excessive bleeding after his sensor removal procedure due to a significantly large incision and the wound was still open even after receiving two stitches.The user required medical attention for the bleeding.

• Brand Name: EVERSENSE SENSOR
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): SENSEONICS INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INCORPORATED; 20415 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: angela bandy ; 20451 seneca meadows parkway; germantown, MD 20876-7005 ; 3024072878
• MDR Report Key: 8651909
• MDR Text Key: 146472213
• Report Number: 3009862700-2019-00021
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021410
• UDI-Public: 00817491021410
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/10/2019
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP04526
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2018
• 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 Outcome(s): Other