MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL CARBIDE BUR CAVITY ROUND FG008; BUR, DENTAL

Catalog Number 123-FG19-008

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); Unspecified Tissue Injury (4559)

Event Date 08/19/2022

Event Type  Injury  

Manufacturer Narrative

Since this event resulted in a serious injury, it is reportable per 21cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.

Event Description

In this event it is reported that while a carbide bur cavity round fg008 was being used the patient suddenly turned his head during the treatment, causing a cut at the corner of his mouth.The patient had no other injury except a cut at the corner of the mouth.The patient's cut was treated simply.The file involved has been scrapped.There is no problem with the product.

Manufacturer Narrative

Summary: involved bur which caused patient injury was not returned and cannot be analyzed.Nothing unusual to report was found during dhr review.Root causes are not identified.We will track this kind of event and monitor the trend.For information, the carbide bur cavity round fg 008 we manufacture are quality cutting tools, and by definition, our instruments can cause injury if they come into contact with flesh or any other part of the body that are not intended to be worked with these instruments.

• Brand Name: CARBIDE BUR CAVITY ROUND FG008
• Type of Device: BUR, DENTAL
• Manufacturer (Section D): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer (Section G): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 15410091
• MDR Text Key: 299769216
• Report Number: 8031010-2022-00634
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 123-FG19-008
• Device Lot Number: 1694190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/01/2022
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1