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

Model Number UI30SD1000

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

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.The device is neither implanted or explanted.Reprocessor does not apply.No concomitant medical products and therapy dates provided.Ind is not applicable.

Event Description

During a standard cleaning, the tip of the instrument broke in the patient's mouth.The dentist advised the patient to go to the emergency room for an x-ray or radiograph.It was reported that the emergency room physician inflated his lung so a scope could be done.It was reported that nothing was found.In a follow-up, the dentist reported that the patient is in good condition.

• Brand Name: HU-FRIEDY MFG. CO., LLC
• Type of Device: ULTRASONIC 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: 6191870
• MDR Text Key: 62914001
• Report Number: 1416605-2016-00009
• 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
• Report Date: 12/19/2016

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: Dental Hygienist
• Device Model Number: UI30SD1000
• Device Catalogue Number: UI30SD1000
• Device Lot Number: 1115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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: 52 YR