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

Model Number	UI30SD10
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
An insert was being removed from hand piece prior to subgingival debridement.It was very difficult to remove therefore, the hygienists hand slipped and was cut by the tip of the insert.

• 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: 8925688
• Report Number: 1416605-2019-00017
• Device Sequence Number: 18895506
• Product Code: ELC
• UDI-Device Identifier: 10889950075613
• UDI-Public: (01)10889950075613(10)0319
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/23/2019

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: 0319
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/23/2019
• 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: 76 YR