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 Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Skin Irritation (2076)

Event Date 01/07/2018

Event Type  Injury  

Manufacturer Narrative

No eval other description: physical product analysis is not required for skin discomfort/irritation complaints because there is no way to determine the level of skin discomfort/irritation through analysis of the physical product.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced a severe reaction to the adhesive on the third wearable sensor that caused blistering around the area where the adhesive was applied.The blisters were 1 inch width and the reaction started a few days after applying the third sensor.The patient was treated at the emergency room and was given antibiotics and steroid injections.The er physician advised discontinuation of wearing the sensor.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: 7415729
• MDR Text Key: 105097675
• Report Number: 3010824444-2018-00003
• 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: 04/10/2018

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 Model Number: P01575-010
• Device Catalogue Number: P01575-010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/15/2017
• 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: 66 YR