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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAVO DENTAL GMBH PROPHYFLEX 3 2018 DENTAL HANDPIECE

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KAVO DENTAL GMBH PROPHYFLEX 3 2018 DENTAL HANDPIECE Back to Search Results
Model Number PROPHYFLEX 3 2018
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Code Available (3191)
Event Date 05/28/2019
Event Type  Injury  
Manufacturer Narrative
It is the nature of an air-flow-system that at the end of the cannula an airflow mixed with water and powder gets exhausted. This is the intended function of the product. To avoid the occurrence of an emphysema the 'instruction of use' contains already a warning that it should be avoided to blow directly in damaged tissue and/or open wounds. From current point of view a use of the product against this request lead to the incident. Product was not evaluated as it was clear from the communication that it works as specified.
 
Event Description
After a tissue excision at tooth #8 a subgingival cleaning with the air-flow-system has been performed. Immediately the right side of face started to swell due to appearance of emphysema. Patient was not able to open the eye anymore. An ambulance has been called and patient was taken to hospital for further treatment. Amoxiclav 875mg was prescribed.
 
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Brand NamePROPHYFLEX 3 2018
Type of DeviceDENTAL HANDPIECE
Manufacturer (Section D)
KAVO DENTAL GMBH
bismarckring 39
biberach / riss, 88400
GM 88400
Manufacturer (Section G)
KAVO DENTAL GMBH
bismarckring 39
biberach / riss, 88400
GM 88400
Manufacturer Contact
klaus reisenauer
bismarckring 39
biberach / riss, 88400
GM   88400
MDR Report Key8752074
MDR Text Key149760111
Report Number3003637274-2019-00026
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K973876
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Dentist
Type of Report Initial
Report Date 07/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPROPHYFLEX 3 2018
Device Catalogue Number1.006.9926
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/06/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/02/2019 Patient Sequence Number: 1
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