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 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.

• Brand Name: PROPHYFLEX 3 2018
• Type of Device: DENTAL 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 Key: 7498748
• MDR Text Key: 107735330
• Report Number: 3003637274-2018-00021
• 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,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 Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: PROPHYFLEX 3 2018
• Device Catalogue Number: 1.000.4672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 27 YR