MAUDE Adverse Event Report: PREMIER DENTAL PRODUCTS COMPANY NITROSPRAY PLUS LITE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	1006065
Medical Device Problem Codes	Fluid/Blood Leak (1250); Gas Output Problem (1266); Material Twisted/Bent (2981); Device Handling Problem (3265)
Health Effect - Clinical Code	Cryogenic Burn (4539)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The spray tube was loose and the needle was broken.The canister has two major dents.No other issues were found with this unit.Based on evaluation, it appears there were "wear and tear" type of issues with these units.Having damaged needles among other issues noted may have contributed with the burn issue as per end customer descriptions.
Event or Problem Description
Prior to contacting the manufacturer on (b)(6) 2021, (b)(6) used nitrospray plus lite to treat a patient.Per the email notification from the associate clinical director: "we use different bore needles (spray tips) to use for cryotherapy & have experienced 4 separate incidences of chemical burns (blistering) after treatment".The physician is trying to understand why this has happened over the past month.She questioned the spray tip sizes & had contacted their gas provider as well.The burns were not serious, one was deeper than the others.She has been advised to send the three units in for evaluation along with spray tips that have been used.This report is for patient 1 out of 3.

• Brand Name: NITROSPRAY PLUS LITE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): PREMIER DENTAL PRODUCTS COMPANY; 1710 romano drive; plymouth meeting PA 19462
• Manufacturer Contact: 10090 sandmeyer lane; philadelphia, PA 19116
• MDR Report Key: 13078677
• Report Number: 2511556-2021-00008
• Device Sequence Number: 12258408
• Product Code: GEH
• UDI-Device Identifier: D6911006065
• UDI-Public: D6911006065
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K970992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2021

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 Model Number: 1006065
• Device Catalogue Number: 1006065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2005
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown