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

Model Number UI30SD10

Device Problem Ejection Problem (4009)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/09/2019

Event Type  Injury  

Event 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
• 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: stephanie wasielewski ; 3232 n rockwell st; chicago, IL 60618
• MDR Report Key: 8925688
• MDR Text Key: 155371763
• Report Number: 1416605-2019-00017
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: 10889950075613
• UDI-Public: (01)10889950075613(10)0319
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 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
• Device Operator: Health Professional
• Device Model Number: UI30SD10
• Device Catalogue Number: UI30SD10
• Device Lot Number: 0319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR