MAUDE Adverse Event Report: EPIC TECHNOLOGIES, LLC SEEQ; DETECTOR AND ALARM, ARRHYTHMIA

Model Number P01575-010

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

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Skin Irritation (2076)

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced "weeping and yellow pus" on the skin from the wearable sensor.The patient "will take a skin pause until (the) skin heals." it is unknown if the sensor was replaced.No further patient complications have been reported as a result of this event.

• Brand Name: SEEQ
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): EPIC TECHNOLOGIES, LLC; 4240 irwin-simpson road; mason OH 45040
• Manufacturer (Section G): EPIC TECHNOLOGIES, LLC; 4240 irwin-simpson road; mason OH 45040
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7658710
• MDR Text Key: 113026808
• Report Number: 3010824444-2018-00006
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133701
• 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: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: P01575-010
• Device Catalogue Number: P01575-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2018
• Date Device Manufactured: 02/27/2018
• 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
• Patient Age: 55 YR