MAUDE Adverse Event Report: BIO PROTECH INC. ECG, SS, DIAPH, FOAM ADULT, TEAR DROP, 5; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	E510DATM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Irritation (2076)
Date of Event	04/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier¿s results of investigation, the device history record review did not indicate any exception that could lead to the reported incident.There were no changes to the materials, product or process for this product.  no sample has been received for investigation as of this report. bio protech tested the retained samples on several participants for 10 hours.There were no abnormalities found after the testing.The root cause could not be determined.There is no additional action taken at this time, but we will continue to monitor the trend of this type of incident.
Event or Problem Description
The electrodes were used for a cath lab procedure and a few days later, marks showed up on the patients body.
Additional Manufacturer Narrative
A sample has been shipped for investigation.The results of investigation are not yet available.A followup report will be filed when the investigation is complete.
Additional Manufacturer Narrative
Based on the suppliers results of investigation the device history record review did not indicate any exception that could lead to the reported incident.There were no changes to the material, product or process for this product.  eleven pouches of electrodes were returned from the customer for investigation.The returned samples were tested on several participants for 10 hours and there were no abnormalities found after the testing.Retained samples were also tested on several participants for 10 hours and no abnormalities were found after the testing. from the investigation the root cause could not be determined.  at this time no additional action will be taken, but we will continue to monitor the trend of this type of incident.

• Brand Name: ECG, SS, DIAPH, FOAM ADULT, TEAR DROP, 5
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): BIO PROTECH INC.; donghwas med. inst. comp. 151-; dongwagongdan-ro, munmak-eup; wonju-si, ganwon-do 220-8 01; KS 220-801
• MDR Report Key: 6576946
• Report Number: 1423537-2017-00095
• Device Sequence Number: 18860923
• Product Code: DRX
• UDI-Device Identifier: 10885380074530
• UDI-Public: 10885380074530
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2017
• Report Date (Section F): 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: E510DATM
• Device Catalogue Number: E510DATM
• Device Lot Number: 160411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Distributor Facility Aware Date: 04/21/2017
• Date Report to Manufacturer: 04/25/2017
• Initial Date Received by Manufacturer: 04/21/2017
• Supplement Date Received by Manufacturer: Not provided; 04/21/2017
• Initial Report FDA Received Date: 05/18/2017
• Supplement Report FDA Received Date: 06/23/2017; 07/07/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 21 YR