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

Model Number UI30SSXT

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/13/2020

Event Type  Injury  

Manufacturer Narrative

Multiple instruments were returned from the customer for evaluation together.The instrument involved in this report was not identified by the customer therefore, we cannot determine the lot code or udi.All of the instruments were evaluated and no device problem was found.

Event Description

While performing a dental cleaning in the lower lingual area the dental hygienist noticed the instrument tip broke off and was no longer visible.There was an attempt to suction the tip out of the patient's mouth.Patient went to a medical clinic for a chest x-ray and the tip was not seen on the x-ray.Patient sifted through stool in the following days and tip was not found.Patient had a 3 month follow up chest x-ray and the tip was not seen on x-ray.

• Brand Name: HU-FRIEDY
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago, il
• Manufacturer (Section G): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago, il
• Manufacturer Contact: stephanie wasielewski ; 3232 n rockwell st.; chicago, il
• MDR Report Key: 10340814
• MDR Text Key: 200876723
• Report Number: 1416605-2020-00003
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UI30SSXT
• Device Catalogue Number: UI30SSXT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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: 92 YR