MAUDE Adverse Event Report: JIFFY; JIFFY ORIGINAL POLISHING POINT WHITE

Model Number 7021

Device Problem Premature Separation (4045)

Patient Problem Aspiration/Inhalation (1725)

Event Type  Injury  

Manufacturer Narrative

This report was due on (b)(6), however due to it restrictions and an expired certificate caused a delay on this report submission.Ultradent has maintained contact with the fda esg help desk throughout that time as evidence that there were esg/certificate/it issues that caused a delay.

Event Description

#7021 jiffy original polishing point--white did not stay latched in the evo.15 micro series by bien air during a restorative procedure.A jiffy point came out of the handpiece during polishing.The patient aspirated the point and per protocol of the of the university they sent the pt to the er.Upon chest x-ray the observed the polishing point.During the bronchoscopy the patient expectorated the point out.From last report given ((b)(6) 2023) patient is doing well.

• Brand Name: JIFFY
• Type of Device: JIFFY ORIGINAL POLISHING POINT WHITE
• MDR Report Key: 16591867
• MDR Text Key: 311775195
• Report Number: 1718912-2023-00001
• Device Sequence Number: 1
• Product Code: EHL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7021
• Device Catalogue Number: 7021
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/23/2023
• Event Location: Other
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EVO .15 MICRO SERIES BY BIEN AIR.
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Female