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

Model Number	UI25SD10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight unknown.No relevant history.The device is not implanted, therefore implant/explant dates are not applicable reprocessor does not apply.No known concomitant medical products and therapy dates.
Event or Problem Description
The dental hygienist was using the ultrasonic instrumentation for a routine preventive care appointment.The patient had a slightly closed mouth and thought he swallowed calculous but, it was the instrument tip.The patient was sent to the emergency room for x-rays and an 8mm part of the tip was found in his stomach.Patient was advised to go back to er if he had any additional stomach pain or fever.

• 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: 8588530
• Report Number: 1416605-2019-00008
• Device Sequence Number: 14001134
• Product Code: ELC
• UDI-Device Identifier: 10889950075361
• UDI-Public: (01)10889950075361(10)0218
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/07/2019

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: UI25SD10
• Device Catalogue Number: UI25SD10
• Device Lot Number: 02/18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/07/2019
• 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: 20 YR