MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC SWIVEL DIRECT FLOW; SCALER, ULTRASONIC

Model Number	UI30SD100
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During a scaling and root planing (srp) procedure, the tip of an instrument broke in a patient's mouth and was swallowed.The patient was referred to the er and it was reported to image dental that the patient was examined and told the tip would pass on its own.

• Brand Name: SWIVEL DIRECT FLOW
• Common Device Name: SCALER, ULTRASONIC
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st; chicago IL 60618
• MDR Report Key: 8719305
• Report Number: 1416605-2019-00012
• Device Sequence Number: 19294009
• Product Code: ELC
• UDI-Device Identifier: 10889950075620
• UDI-Public: (01)10889950075620(10)1116
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K012060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2019

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: UI30SD100
• Device Catalogue Number: UI30SD100
• Device Lot Number: 11/16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/20/2019
• 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: 24 YR