MAUDE Adverse Event Report: PREMIER DENTAL PRODUCTS CO. NITROSPRAY PLUS; CRYOSURGICAL UNIT

Model Number	1006060
Medical Device Problem Codes	Free or Unrestricted Flow (2945); Misassembly by Users (3133)
Health Effect - Clinical Codes	Blister (4537); Cryogenic Burn (4539)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During the interview with the office, it was disclosed that a spray tip was not applied to the nitrospray plus nozzle.The instructions for use were not followed.Original mfr report number 2511556-2020-00001 was filed.
Event or Problem Description
Due to user error, two patients had blistering after treatment.Patients were monitored for healing, both burns were not serious and did not require medical treatment.This is the mdr report for the 2nd patient.
Additional Manufacturer Narrative
During the interview with the office, it was disclosed that a spray tip was not applied to the nitrospray plus nozzle.The instructions for use were not followed.Submitting report again to correct the error of summary report box being checked.
Event or Problem Description
Due to user error, two patients had blistering after treatment.Patients were monitored for healing, both burns were not serious and did not require medical treatment.

• Brand Name: NITROSPRAY PLUS
• Common Device Name: CRYOSURGICAL UNIT
• Manufacturer (Section D): PREMIER DENTAL PRODUCTS CO.; 1710 romano drive; plymouth meeting PA 19462
• MDR Report Key: 11761062
• Report Number: 2511556-2020-00002
• Device Sequence Number: 4503420
• Product Code: GEH
• UDI-Device Identifier: D6911006060
• UDI-Public: D6911006060
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K970992
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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: 1006060
• Device Catalogue Number: 1006060
• Device Lot Number: 14623
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 06/08/2021
• 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