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 Laceration(s) (1946)

Event Date 01/12/2024

Event Type  Injury  

Manufacturer Narrative

Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr part 803.Investigation: 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.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.

Event Description

In this event it is reported that carb.Bur cav.Cyl.Square fg 012 scratched the tongue of a patient that is a child due to the child's tongue movement.The file scratched the tongue mucosa and there was a small amount of bleeding.Immediately, cotton ball was used to compress the area to stop the bleeding.Follow up on the patient the next day and the child had no discomfort.

• 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: 18649327
• MDR Text Key: 334618761
• Report Number: 8031010-2024-00006
• 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
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• 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: 01/29/2024
• Date Manufacturer Received: 01/29/2024
• Type of Device Usage: A
• Patient Sequence Number: 1