MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL CARB.B.CAV.CONE SQUARE FG 012; BUR, DENTAL

Catalog Number E013834101200

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

Patient Problem Laceration(s) (1946)

Event Date 06/19/2023

Event Type  Injury  

Event Description

In this event it is reported that a unknown maillefer bur (fg-701) during use cut patient's left tongue.Cut was sutured and oral anti-inflammatory rx was given.Reportedly, patient is now fine.

Manufacturer Narrative

As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.Investigation: no product and no lot# available.No investigation or dhr review can be done.Root causes are not identified.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.

Manufacturer Narrative

Additional information received: the lot # has been provided - lot # 1760368.Adding udi # (b)(4).Dhr investigation results: summary: involved product was not returned and cannot be analyzed.Nothing unusual to report was found during dhr review (batch #1760368).Root causes are not identified.We will track this kind of event and monitor the trend.With this investigation information: additional fda coding being added after investigation of device.Adding additional type of investigation code 3331.This is a follow up report to add this additional code.Device received for this event is being corrected from unk maillefer catalog # unknown to carb.B.Cav.Cone square fg 012 catalog # e013834101200.With the lot# known for this event, dhr investigation was completed.This has changed the codes that were previously submitted on the initial report.This is to correct and remove the codes that were initially reported - removing codes for: investigation findings code - 3221.The correct codes for this complaint are: investigation findings code - 213.This is a follow up report to report these corrections.

• Brand Name: CARB.B.CAV.CONE SQUARE FG 012
• 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: 17650804
• MDR Text Key: 322286922
• Report Number: 8031010-2023-00836
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: E013834101200
• Device Lot Number: NOT PROVIDE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/21/2023
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1