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

Model Number UI25SD10

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Patient weight unknown.No relevant history.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

The dental hygienist was using the ultrasonic instrumentation for a routine preventive care appointment.The patient had a slightly closed mouth and thought he swallowed calculous but, it was the instrument tip.The patient was sent to the emergency room for x-rays and an 8mm part of the tip was found in his stomach.Patient was advised to go back to er if he had any additional stomach pain or fever.

• 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: maria vrabie ; 3232 n rockwell st; chicago, IL 60618 ; 7738685676
• MDR Report Key: 8588530
• MDR Text Key: 144398670
• Report Number: 1416605-2019-00008
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: 10889950075361
• UDI-Public: (01)10889950075361(10)0218
• 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: 05/07/2019

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: UI25SD10
• Device Catalogue Number: UI25SD10
• Device Lot Number: 02/18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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: 20 YR