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

Model Number	UI30SD10
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During a dental cleaning the tip of an insert broke in the patient's mouth.The patient was sent to hospital for an x-ray and a 2mm piece was found in his abdomen.Patient was told to let the piece pass and no additional treatment was necessary.

• Brand Name: HU-FRIEDY SWIVEL DIRECT FLOW INSERTS
• Common Device Name: SCALER, ULTRASONIC
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st; chicago IL 60618
• MDR Report Key: 8758466
• Report Number: 1416605-2019-00014
• Device Sequence Number: 13838288
• Product Code: ELC
• UDI-Device Identifier: 10889950075613
• UDI-Public: (01)10889950075613(10)0518
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/03/2019

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: UI30SD10
• Device Catalogue Number: UI30SD10
• Device Lot Number: 0518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 07/03/2019
• 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: 78 YR