MAUDE Adverse Event Report: VOCO GMBH CLEAN JOY

Catalog Number REF 2090

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling/ Edema (4577)

Event Date 03/22/2021

Event Type  Injury  

Manufacturer Narrative

Clean joy contains artificial flavors.Intolerances to these ingredients cannot be ruled out in rare cases.The instructions for use contain appropriate warnings.

Event Description

After treatment with cleanjoy mint and voco profluoride varnish melon, a patient complained of swelling on her face.The patient went to the emergency room on the advice of the treating dentist.There was no inpatient admission.Two days after treatment, the patient reported an improvement in her condition.This is report 2 of 2.

• Brand Name: CLEAN JOY
• Type of Device: CLEAN JOY
• Manufacturer (Section D): VOCO GMBH; anton-flettner-stra?e 1-3; cuxhaven, niedersachsen 27472 ; GM 27472
• Manufacturer (Section G): VOCO GMBH; anton-flettner-stra?e 1-3; cuxhaven, niedersachsen 27472 ; GM 27472
• Manufacturer Contact: michael cyll ; anton-flettner-stra?e 1-3; cuxhaven, niedersachsen 27472 ; GM 27472
• MDR Report Key: 11663507
• MDR Text Key: 245327185
• Report Number: 8010908-2021-00003
• Device Sequence Number: 1
• Product Code: EJR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: D173566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: REF 2090
• Device Lot Number: 2038017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR