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

Model Number N305

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

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

Event Date 04/30/2018

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation.

Event Description

Circular rash with blisters was noticed on patient's skin.

• Brand Name: NEOTECH PRODUCTS LLC
• Type of Device: RADIOLUCENT NEOLEADS
• Manufacturer (Section D): NEOTECH PRODUCTS LLC; 28430 witherspoon parkway; valencia 91355
• Manufacturer (Section G): NEOTECH PRODUCTS LLC; 28430 witherspoon pkw; valencia CA 91355
• Manufacturer Contact: ben mahajan ; 28430 witherspoon parkway; valencia, CA 91355 ; 6617757466
• MDR Report Key: 7542305
• MDR Text Key: 109187750
• Report Number: 2025917-2018-00106
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 00812594010293
• UDI-Public: 00812594010293
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Model Number: N305
• Device Catalogue Number: N305
• Device Lot Number: 2017-9012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 DA
• Patient Weight: 2