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U.S. Department of Health and Human Services

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

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EPIC TECHNOLOGIES, LLC SEEQ DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
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)
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.

 
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Brand NameSEEQ
Type of DeviceDETECTOR 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 Key7415748
MDR Text Key105141240
Report Number3010824444-2018-00004
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK133701
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 04/10/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/10/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberP01575-010
Device Catalogue NumberP01575-010
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/16/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/15/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/10/2018 Patient Sequence Number: 1
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