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

Model Number UI30SD10

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/08/2019

Event Type  Injury  

Event Description

During a dental cleaning the tip of an insert broke in the patient's mouth.The patient was sent to hospital for an x-ray and a 2mm piece was found in his abdomen.Patient was told to let the piece pass and no additional treatment was necessary.

• Brand Name: HU-FRIEDY SWIVEL DIRECT FLOW INSERTS
• 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
• MDR Report Key: 8758466
• MDR Text Key: 149966687
• Report Number: 1416605-2019-00014
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: 10889950075613
• UDI-Public: (01)10889950075613(10)0518
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• 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: 0518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2018
• 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: 78 YR