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

Catalog Number 137-FG19-012

Device Problem Break (1069)

Patient Problem Abrasion (1689)

Event Date 12/19/2023

Event Type  Injury  

Event Description

In this event it is reported that carb.Bur cav.Cyl.Square fg 012 reportedly scratched the tongue mucosa of a child patient causing slight bleeding.Compression of the area by a cotton ball was applied.The bleeding was successfully stopped.

Manufacturer Narrative

There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event 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.

Manufacturer Narrative

Summary: involved product was not returned and cannot be analyzed.Nothing unusual to report was found during dhr review (batch #1708979).Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: CARB.BUR CAV.CYL.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: 18424433
• MDR Text Key: 331801028
• Report Number: 8031010-2024-00891
• 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: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 137-FG19-012
• Device Lot Number: 1708979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/21/2023
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1