MAUDE Adverse Event Report: HU-FRIEDY MFG. CO., LLC HU-FRIEDY SCALER DE H6/H7 8HDL; PERIODONTAL SCALER

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/19/2013

Event Type  malfunction  

Event Description

During a dental procedure involving a routine cleaning and taking impressions for a partial, the tip of a scaler broke off in the patient's mouth.After the procedure, x-rays were taken and it was determined that the tip was in the patient's stomach.Surgery was conducted and the tip was successfully removed from the patient's stomach.All events occurred on (b)(6) 2013.The above events were described to hu-friedy by the initial reporter on (b)(6) 2014.Hu-friedy could not confirm the accuracy of these events or if it was their instrument involved in these events.

Manufacturer Narrative

Information provided could not be confirmed because the instrument was not returned.All remaining n/a in this section are not known because the instrument was not returned to hu-friedy.This is a class i exempt device.

• Brand Name: HU-FRIEDY SCALER DE H6/H7 8HDL
• Type of Device: PERIODONTAL SCALER
• Manufacturer (Section D): HU-FRIEDY MFG. CO., LLC; 3232 north rockwell st.; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MFG. CO.,INC.; 3232 north rockwell st.; chicago IL 60618
• Manufacturer Contact: maria vrable, director ; 3232 north rockwell st.; chicago, IL 60618 ; 7738685676
• MDR Report Key: 3865213
• MDR Text Key: 4567466
• Report Number: 1416605-2014-00001
• Device Sequence Number: 1
• Product Code: EMN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Dentist
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: NO CONCOMITANT MEDICAL PRODUCTS AND THERAPY; DATES REPORTED
• Patient Outcome(s): Other