MAUDE Adverse Event Report: BIO PROTECH INC ELECTRODE, ECG, PREWIRED, NEONATAL, CLOT; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	EPP3CR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Lead(s), Burn(s) From (3161)
Date of Event	07/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the supplier¿s results of investigation, all materials, production processes and inspections met the specification requirements for the neonatal electrode code epp3cr.The device history record review did not indicate any exception that could lead to the reported incident.The supplier investigated and conducted clinical tests and the results did not reveal any negative skin issues.This is the first complaint of this type for this product.From the investigation the root cause could not be determined.No additional action will be taken at this time, but we will continue to monitor the trend for this type of incident.
Event or Problem Description
User facility reported a possible burn from neonatal leads.Leads were changed 24 hours prior to event date (b)(6) 2017.At time of event bedside nurse changed leads to the neolead micro electrodes.Green lead was affected and changed.Patient site reviewed and left mid abdomen found to have an intact flat blister circular 1 cm x 1 cm area with a faint erythematous circular region the size of the electrode.Flat blister appears intact with scant dry exudate.

• Brand Name: ELECTRODE, ECG, PREWIRED, NEONATAL, CLOT
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): BIO PROTECH INC; donghwas med. inst. comp.151-3; dongwagongdan-ro, munmak-eup; wonju-si, ganwon-do 220-8 01; KS 220-801
• MDR Report Key: 6846555
• Report Number: 1423537-2017-00122
• Device Sequence Number: 1600092
• Product Code: DRX
• UDI-Device Identifier: 00885380048473
• UDI-Public: 00885380048473
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2017
• Report Date (Section F): 07/20/2017

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: EPP3CR
• Device Catalogue Number: EPP3CR
• Device Lot Number: 170206
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/14/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2017
• Initial Report FDA Received Date: 09/06/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 07/20/2017