MAUDE Adverse Event Report: NEOTECH PRODUCTS LLC NEOTECH PRODUCTS LLC; RADIOLUCENT NEOLEADS

Model Number	N305
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	04/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.
Event or Problem Description
Circular rash/burn with white papules/blisters was noticed on patient's skin.

• Brand Name: NEOTECH PRODUCTS LLC
• Common Device Name: RADIOLUCENT NEOLEADS
• Manufacturer (Section D): NEOTECH PRODUCTS LLC; 28430 witherspoon parkway; valencia CA 91355
• MDR Report Key: 7539155
• Report Number: 2025917-2018-00104
• Device Sequence Number: 1898430
• Product Code: DRX
• UDI-Device Identifier: 00812594010293
• UDI-Public: 00812594010293
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K011564
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Remedial Action: Inspection,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2019
• Device Model Number: N305
• Device Catalogue Number: N305
• Device Lot Number: 2017-9011
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 2 MO
• Patient Weight: 5