MAUDE Adverse Event Report: HU-FRIEDY MFG. CO., LLC HU-FRIEDY; DENTAL ULTRASONIC SCALER INSERT

Model Number UI30SSXT

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Type  No Answer Provided  

Manufacturer Narrative

No additional information about the event was provided, and the device in question has not yet been returned for evaluation.

Event Description

Dental ultrasonic scaler insert tip reported to have broken in patient's mouth.It was reported that patient swallowed tip and went to emergency room.

Manufacturer Narrative

Returned instrument tips were broken about 3 mm from the end.No issues of breakage have been identified during final inspection of product.Patient identifier, age/date of birth, and weight unknown.Date of event unknown.Hu-friedy does not track our devices (which are mostly low risk class 1 devices) by serial number or udi, only by a lot number, which is tied to the date of manufacture.The product involved in the event does not have an expiration date.The device is not implanted, therefore implant/explant dates are not applicable.Reprocessor does not apply.Concomitant medical products: no concomitant medical products and therapy dates provided.

Event Description

Dental ultrasonic scaler insert tip reported to have broken in patient's mouth.It was reported that patient swallowed tip and went to emergency room.Then the patient went to her regular doctor for an x-ray and confirmed the broken piece was in patient's stomach.The patient has followed up with her doctor and hasn't had any recurring issues.

• Brand Name: HU-FRIEDY
• Type of Device: DENTAL ULTRASONIC SCALER INSERT
• 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: 5243244
• MDR Text Key: 31908594
• Report Number: 1416605-2015-00006
• 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: health professional,user faci
• Reporter Occupation: Dental Hygienist
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2016

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: No Information
• Device Model Number: UI30SSXT
• Device Catalogue Number: UI30SSXT
• Device Lot Number: 0415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2015
• Initial Date FDA Received: 11/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other