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 Erythema (1840); Unspecified Infection (1930); Itching Sensation (1943); Skin Irritation (2076); Tissue Breakdown (2681)

Event Date 12/04/2017

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 patient wore the fourth wearable sensor and experienced severe skin irritation beneath the sensor.The patient also stated that the skin looks infected and "is red, itches, (and) bleeds when scratched." there are several spots on the chest area that are "oozing clear liquid and is very moist." 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: 7255542
• MDR Text Key: 99564533
• Report Number: 3010824444-2018-00002
• 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: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/05/2017
• 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: 28 YR