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

Model Number UI25SD100

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/17/2016

Event Type  malfunction  

Manufacturer Narrative

On 12/21/2016, it was reported to us by (b)(6) that the instrument broke in the patient's mouth.The user facility contacted (b)(6), who forwarded the complaint to hu-friedy.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.No concomitant medical products and therapy dates provided.Device not received.

Event Description

It was reported to us that the patient was having scaling done when the tip of the scaler broke in the patient's mouth.

Manufacturer Narrative

This is a follow-up report containing information after the device was received and evaluated.The device was initially reported as ui30sd100.The device that was returned and subsequently evaluated was ui25sd100.

Event Description

It was reported to us that the patient was having scaling done when the tip of the scaler broke in the patient's mouth.

• Brand Name: HU-FRIEDY MFG. CO., LLC
• Type of Device: ULTRASONIC SCALER
• 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: 6200726
• MDR Text Key: 63203726
• Report Number: 1416605-2016-00010
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2016

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: UI25SD100
• Device Catalogue Number: UI25SD100
• Device Lot Number: 1214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2014
• 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: 61 YR