MAUDE Adverse Event Report: KAVO DENTAL GMBH KAVO GENTLEMINI LUX 4500BR; DENTAL HANDPIECE

Model Number 4500 BR

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/30/2020

Event Type  Injury  

Event Description

The dentist was performing a dental procedure using a kavo 4500br dental handpiece when allegedly the dental bur from another manufacturer (3300 brasser) separated from the handpiece.The dental dealer said the patient thought that she swallowed the 330 brassler bur.Patient was advised to go to emergency room on site.Patient had a chest x-ray and ct scan, neither of which indicated that she actually swallowed the bur.Patient was discharged in good condition.There were no injuries reported.

• Brand Name: KAVO GENTLEMINI LUX 4500BR
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarckring 39; biberach / riss 88400 ; GM 88400
• MDR Report Key: 10523292
• MDR Text Key: 206589501
• Report Number: 1017522-2020-00012
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4500 BR
• Device Catalogue Number: 1.007.1700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/11/2020
• Distributor Facility Aware Date: 08/14/2020
• Device Age: 10 YR
• Event Location: Other
• Date Report to Manufacturer: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR