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

Model Number	UI30SD1000
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
An employee was taking off a cavitron insert and the rubber cap slipped off causing her hand to come in contact with the end of the insert which, nicked her right finger.

• 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: 8719516
• Report Number: 1416605-2019-00011
• Device Sequence Number: 1993108
• Product Code: ELC
• UDI-Device Identifier: 10889950075637
• UDI-Public: (01)10889950075637(10)1118
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Dentist
• 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: UI30SD1000
• Device Catalogue Number: UI30SD1000
• Device Lot Number: 11/18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2019
• 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: 20 YR
• Patient Weight: 54