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

Model Number 102096-67A

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/22/2021

Event Type  Injury  

Event Description

On october 21st 2021, senseonics was made aware of an adverse event where patient noticed about 1.5 hours after the removal procedure the incision was bleeding through her tegaderm.Patient's husband took off the coban, and tegaderm and steri-strips had fallen off.User visited emergency room.Er attempted to stop the bleeding by applying dermabond and a pressure dressing.It continued to bleed through.Er placed a staple to her incision that completely stopped the bleeding.Patient was prescribed with keflex and is doing fine and no further actions to be taken.

Manufacturer Narrative

The patient noticed about 1.5 hours after the removal procedure the incision was bleeding through her tegaderm.Patient's husband took off the coban, and tegaderm and steri-strips had fallen off.User visited emergency room.Er attempted to stop the bleeding by applying dermabond and a pressure dressing.It continued to bleed through.Er placed a staple to her incision that completely stopped the bleeding.Patient was prescribed with keflex and is doing fine and no further actions to be taken.

• 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 Key: 12850171
• MDR Text Key: 281077143
• Report Number: 3009862700-2021-00139
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491022349
• UDI-Public: 00817491022349
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2021

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: 04/23/2022
• Device Model Number: 102096-67A
• Device Catalogue Number: FG-4200-00-301
• Device Lot Number: WP08507
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/21/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/03/2021
• 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): Hospitalization
• Patient Age: 52 YR
• Patient Sex: Female