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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); 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.

 
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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 Key7255542
MDR Text Key99564533
Report Number3010824444-2018-00002
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 02/08/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/08/2018
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 Manufacturer12/20/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/05/2017
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: 02/08/2018 Patient Sequence Number: 1
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