MAUDE Adverse Event Report: VOCO GMBH VOCO CLIP

Device Problems Biocompatibility (2886); Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)

Event Date 08/02/2023

Event Type  Injury  

Event Description

Incident description received from mhra with user report (b)(4): "patient had temporary filling material placed after a crown preparation.Material is called 'clip' and manufactured by voco for dental use.Patient disclosed allergy to gel names and when ingredients cross-matched methacrylate was the commonality.Patient tested small amount of clip against skin and redness resulted to confirm allergy.We replaced the temporary material and no further problems.Patient had taken an antihistamine and ibuprofen and encouraged salted mouthwashes for symptomatic relief.Where was the medicine obtained: "dental source voco" do you think this reaction occurred as a result of a mistake made in the prescription, dosing, dispensing or administration of the medication?: "no" reason: dental care.Reaction: redness.Reaction: mouth swelling.".

• Brand Name: VOCO CLIP
• Type of Device: CLIP
• 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: 17884848
• MDR Text Key: 325069845
• Report Number: 8010908-2023-00005
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K926418
• 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: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• 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