MAUDE Adverse Event Report: VOCO GMBH FUTURABOND M+

Catalog Number REF 1515

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

Patient Problem Rash (2033)

Event Date 11/01/2021

Event Type  Injury  

Event Description

One patient received treatment under general anesthesia approximately 6 weeks ago.During this session, two small composite fillings (11 and 38) were placed and five ceramic inlays were fabricated and cemented in place.According to the patient, he has not been well since this treatment.He had a skin rash all over his body.The patient is currently being treated by a dermatologist.The products used had been given to the treating physician for testing.With futurabond m+, there had been an anomaly.It is not known what this abnormality consisted of.The following products were used for the treatment: tetric evo ceran - ivoclar vivadent, tetric evo flow - ivoclar vivadent, estelite universal flow - tokuyama dental, cerec inlays, futurabond m+ - voco gmbh.

Manufacturer Narrative

Futurabond m+ contains organic acids, (di-)methacrylates, amines (dabe) and bht.Intolerances/allergies to these ingredients cannot be excluded.The instructions for use contain corresponding warnings.In general, futurabond m+ has only a very low allergenic potential when used correctly.The adhesive is used in very small quantities and sealed by the composite filling after polymerization.In our opinion, it is unlikely that the incident was caused by futurabond m+.We are not aware of any similar cases related to futurabond m+.According to our information, the dentist used estelite universal flow from tokuyama dental for bonding the ceramic inlays.This indication is not covered by the manufacturer for this product.The purely light-curing product will possibly not polymerize or polymerize insufficiently under a ceramic restoration.This may result in prolonged and undesirable exposure of the patient to free methacrylates and may leading to the reported persistent reactions.

• Brand Name: FUTURABOND M+
• Type of Device: FUTURABOND M+
• Manufacturer (Section D): VOCO GMBH; anton-flettner-strasse 1-3; cuxhaven, niedersachsen 27472 ; GM 27472
• Manufacturer (Section G): 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: 13024172
• MDR Text Key: 288112821
• Report Number: 8010908-2021-00009
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: REF 1515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Sex: Male