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

Model Number UI30SD1000

Device Problem Ejection Problem (4009)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/24/2019

Event Type  Injury  

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 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
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st; chicago IL 60618
• Manufacturer Contact: matt berns ; 3232 n rockwell st; chicago, IL 60618 ; 7738683550
• MDR Report Key: 8719516
• MDR Text Key: 148799592
• Report Number: 1416605-2019-00011
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: 10889950075637
• UDI-Public: (01)10889950075637(10)1118
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR
• Patient Weight: 54