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); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Itching Sensation (1943); Skin Irritation (2076)

Event Date 01/06/2018

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 severe redness and blisters from the wearable sensor and a severe allergic reaction to the second sensor.The skin was red, itchy and blistery.The patient went to the emergency room and was given antibiotics and a steroidal injection.The physician recommended that the patient not apply another 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: 7415669
• MDR Text Key: 105122845
• Report Number: 3010824444-2018-00005
• 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: 01/06/2018
• 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