MAUDE Adverse Event Report: KAVO DO BRASIL INDUSTRIA E COMERCIO LTDA HENRY SCHEIN MAXIMA PRO 45 N/O FIXED END; HANDPIECE

Model Number MAXIMA PRO 45

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Air Embolism (1697); Swelling (2091)

Event Date 06/24/2019

Event Type  Injury  

Event Description

While performing a surgical extraction on a female patient, the dentist noticed swelling around the patient's face and was concerned that the exhaust air may have contaminated the extraction site.Patient was diagnosed to have developed subcutaneous emphysema and was submitted to an urgent care facility overnight.The patient was monitored and released the subsequent day.

• Brand Name: HENRY SCHEIN MAXIMA PRO 45 N/O FIXED END
• Type of Device: HANDPIECE
• Manufacturer (Section D): KAVO DO BRASIL INDUSTRIA E COMERCIO LTDA; rua chapeco; 86; joinville, 89.22 1-04; BR 89.221-040
• MDR Report Key: 8796460
• MDR Text Key: 151264515
• Report Number: 3007007357-2019-00004
• 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: 07/16/2019,07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAXIMA PRO 45
• Device Catalogue Number: 112-6771
• Device Lot Number: 1705044
• 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: 07/16/2019
• Distributor Facility Aware Date: 07/08/2019
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/16/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization