MAUDE Adverse Event Report: HU-FRIEDY MFG. CO., LLC HU-FRIEDY STREAMLINE DIRECT FLOW, 30K; ULTRASONIC SCALER, PRODUCT CODE: ELC

Model Number UI30SFXT

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/20/2017

Event Type  malfunction  

Manufacturer Narrative

Other relevant history: no relevant medical history.The device was produced before the udi compliance due date for the product and therefore udi was not applied.The product involved in the event does not have an expiration date.Implant date: the device is not implanted.Explant date: the device is not explanted.Concomitant medical products and therapy dates are unknown.Pma 510(k): the (a) nda number and bla number are not applicable to this class 2 device.No protocol numbers are relevant.If follow us what type: this is not a follow-up.This is an initial report.No remedial action initiated.No correction/removal initiated.

Event Description

It was reported to hu-friedy mfg.Co., llc that the hygienist was performing a scaling and root planing procedure when the tip of the instrument broke in the patient's mouth.The patient reportedly swallowed the tip.

Manufacturer Narrative

The model number and catalog number on the initial report was incorrectly reported to us by the initial reporter.This update is to correct the model and catalog number involved in this adverse incident.

Manufacturer Narrative

Brand name has been updated.This is a follow-up report.Follow-up type has been updated.Conclusion code has been updated.

Event Description

It was reported to hu-friedy mfg.Co., llc that the hygienist was performing a scaling and root planing procedure when the tip of the instrument broke in the patient's mouth.The patient reportedly swallowed the tip.

• Brand Name: HU-FRIEDY STREAMLINE DIRECT FLOW, 30K
• Type of Device: ULTRASONIC SCALER, PRODUCT CODE: ELC
• 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: 6498167
• MDR Text Key: 72992167
• Report Number: 1416605-2017-00002
• Device Sequence Number: 1
• Product Code: ELC
• 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: user facility
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2017

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: Dental Hygienist
• Device Model Number: UI30SFXT
• Device Catalogue Number: UI30SFXT
• Device Lot Number: 0316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2017
• Initial Date FDA Received: 04/17/2017
• Supplement Dates Manufacturer Received: Not provided; 03/20/2017
• Supplement Dates FDA Received: 05/05/2017; 08/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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: 34 YR