MAUDE Adverse Event Report: VOCO GMBH MERON APPLICATION CAPSULE; GLASS IONOMER LUTING CEMENT

Model Number REF 1243

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

Patient Problem Pain (1994)

Event Date 01/28/2019

Event Type  Injury  

Manufacturer Narrative

The testing of the manufacturing and release documentation did not reveal any deviations.Contact was made with the dentist in charge in order to clarify possible causes of the problems.A clear cause could not be identified.A product defect, as the cause of the problems described, is not identified.

Event Description

A dentist complained that he had been having problems using meron application capsules since about 4 weeks.In at least 15 cases, patients complained of pain one day after the restoration was inserted.In at least 10 cases an endodontic treatment had been carried out.Details on the patients and the individual treatment procedures are not available.Various crowns and bridges were attached.

• Brand Name: MERON APPLICATION CAPSULE
• Type of Device: GLASS IONOMER LUTING CEMENT
• Manufacturer (Section D): VOCO GMBH; anton-flettner-strasse 1-3; cuxhaven, niedersachsen 27472 ; GM 27472
• Manufacturer Contact: michael cyll ; anton-flettner-strasse 1-3; cuxhaven, niedersachsen 27472 ; GM 27472
• MDR Report Key: 8331504
• MDR Text Key: 135888887
• Report Number: 8010908-2019-00001
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130421
• 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: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: REF 1243
• Device Lot Number: 1826554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other