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

Model Number REF 1243

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Irritation (1941); Increased Sensitivity (2065)

Event Date 02/08/2019

Event Type  Injury  

Manufacturer Narrative

A product defect, as the cause of the problems described, is not detectable.

Event Description

During a visit by our sales representative, the dentist claimed that he has had several problems after the definitive insertion of restorations on vital teeth.Some patients had complained about pulp irritations, hypersensitivities or bite sensitivity (despite good occlusion).The restorations were removed as a precautionary measure and initially provisionally restored.The symptoms then immediately subsided.The further treatment was carried out without complications.

• 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: 8361393
• MDR Text Key: 136869110
• Report Number: 8010908-2019-00003
• 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: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: REF 1243
• Device Lot Number: 1841535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention