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U.S. Department of Health and Human Services

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

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KAVO DO BRASIL INDUSTRIA E COMERCIO LTDA HENRY SCHEIN MAXIMA PRO 45 N/O FIXED END HANDPIECE Back to Search Results
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.
 
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Brand NameHENRY SCHEIN MAXIMA PRO 45 N/O FIXED END
Type of DeviceHANDPIECE
Manufacturer (Section D)
KAVO DO BRASIL INDUSTRIA E COMERCIO LTDA
rua chapeco
86
joinville, 89.22 1-04
BR 89.221-040
MDR Report Key8796460
MDR Text Key151264515
Report Number3007007357-2019-00004
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received07/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMAXIMA PRO 45
Device Catalogue Number112-6771
Device Lot Number1705044
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/16/2019
Distributor Facility Aware Date07/08/2019
Device Age1 YR
Event Location Outpatient Treatment Facility
Date Report to Manufacturer07/16/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/16/2019 Patient Sequence Number: 1
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