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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 04/06/2018
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 wrong use of the product lead to the incident. Product was not returned for analysis, yet. In case it gets returned and the analysis brings new findings a follow up report will be sent.
 
Event Description
Described is that during the treatment with the product (an air-flow-system) the user suddenly noticed that the right eye was swollen. Patient was not able to open the eye anymore. Dental staff directly cooled the area and called an emergency physician. It was clarified that it was not an anaphylactic reaction but an emphysema. To be on the safe side the patient has been brought to hospital for 3 days to monitor her.
 
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Brand NamePROPHYFLEX 3 2018
Type of DeviceDENTAL HANDPIECE
Manufacturer (Section D)
KAVO DENTAL GMBH
bismarckring 39
biberach / riss, bw 88400
GM 88400
Manufacturer (Section G)
KAVO DENTAL GMBH
bismarckring 39
biberach / riss, bw 88400
GM 88400
Manufacturer Contact
klaus reisenauer
bismarckring 39
biberach / riss, bw 88400
GM   88400
MDR Report Key7498748
MDR Text Key107735330
Report Number3003637274-2018-00021
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,other
Reporter Occupation Dentist
Type of Report Initial
Report Date 05/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Dentist
Device Model NumberPROPHYFLEX 3 2018
Device Catalogue Number1.000.4672
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/12/2018
Was Device Evaluated by Manufacturer? No
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: 05/09/2018 Patient Sequence Number: 1
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