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

Model Number EPP3CR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Lead(s), Burn(s) From (3161)

Event Date 07/20/2017

Event Type  Injury  

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 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
• Type of Device: 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
• Manufacturer (Section G): BIO PROTECH INC; donghwas med. inst. comp.151-3; dongwagongdan-ro, munmak-eup; wonju-si, ganwon-do 220-8 01; KS 220-801
• Manufacturer Contact: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 6846555
• MDR Text Key: 85089691
• Report Number: 1423537-2017-00122
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 00885380048473
• UDI-Public: 00885380048473
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2017,09/06/2017

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
• Device Operator: 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
• Date Report Sent to FDA: 07/20/2017
• Distributor Facility Aware Date: 08/14/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2017
• Initial Date Manufacturer Received: 08/14/2017
• Initial Date FDA Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other