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

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.

• Brand Name: PROPHYFLEX 3 2018
• Type of Device: DENTAL 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 Key: 8752074
• MDR Text Key: 149760111
• Report Number: 3003637274-2019-00026
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K973876
• Number of Events Reported: 1
• 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 Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PROPHYFLEX 3 2018
• Device Catalogue Number: 1.006.9926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/06/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR