MAUDE Adverse Event Report: KULZER GMBH - HQ VENUS PEARL; MATERIAL, TOOTH SHADE, RESIN

Catalog Number 66048141

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

Patient Problems Discomfort (2330); Numbness (2415); Weight Changes (2607)

Event Date 07/21/2023

Event Type  Injury  

Manufacturer Narrative

This incident is reportable according to 21 cfr 803.The fda defines this as a serious injury(21 cfr sec.803.3) as the patient reported symptoms they believe stem from an allergic type reaction.The incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.A patient reported experiencing a bad taste in mouth, loss of appetite, weight loss, and lower leg numbness after placement of venus pearl a2 restoration in 2020.Restoration was removed approximately 3 months after placement.Per patient, symptoms fully resolved approximately 1.5 years later.Patient did not seek medical care from physician during course of symptoms, so no diagnosis was given.Patient reported having a chemical sensitivity test completed in the past and previous dentist stated only venus diamond a2 was compatible with patient, but venus pearl a2 was accidentally placed instead.We are unable to confirm what type of test was given to patient to determine dentist's conclusions as dentist has since passed.Currently, there appears to be no standardized test regarding multiple chemical sensitivities in patients to fully differentiate from other diagnoses.Venus diamond and venus pearl are very similar in chemical makeup.The described symptoms reported by patient do not fit the typical symptoms of a chemical sensitization or allergic reaction.The ifu for venus composites acknowledges the sensitization potential due to certain components and recommends to not use in cases of known or suspected allergies.We will report this incident out of abundance of caution.

Event Description

Patient reports bad taste in mouth, loss appetite, weight loss, lower leg numbness after composite restoration placed in mouth.Patient reports having chemical sensitivity to composite.

• Brand Name: VENUS PEARL
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): KULZER GMBH - HQ; leipziger strasse 2; hanau, hesse 63450 ,; GM 63450,
• Manufacturer (Section G): KULZER GMBH - WEHRHEIM; philipp-reis-strasse 8/13; wehrheim, hesse 61273 ; GM 61273
• Manufacturer Contact: matthias hartmann ; leipziger strasse 2; hanau, hesse 63450 ; GM 63450
• MDR Report Key: 17570333
• MDR Text Key: 321405570
• Report Number: 3005665377-2023-00005
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66048141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female