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

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Local Reaction (2035)

Event Date 06/21/2019

Event Type  Injury  

Manufacturer Narrative

The user had an adverse allergic reation to the white adhesive patches.The user has had a mild allergic reaction to adhesives in the past.As of (b)(6) 2019 it was reported that the user was put on a concomitant therapy which resolved the allergic reaction.

Event Description

On (b)(6) 2019 senseonics was made aware of a an event where a user experienced an adverse allergic reaction to the white adhesive patch that resulted in redness, excoriation or ulceration.The patient was treated with a concomitant therapy.No additional information has been provided.

• Brand Name: EVERSENSE ADHESIVE PATCH
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): SENSEONICS INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: angela bandy ; 20451 seneca meadows parkway; germantown, MD 20876-7005 ; 3014072878
• MDR Report Key: 8834404
• MDR Text Key: 152476694
• Report Number: 3009862700-2019-00047
• Device Sequence Number: 1
• Product Code: QCD
• 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: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 57 YR