MAUDE Adverse Event Report: KULZER, GMBH-HQ VENUS DIAMOND PLT REFILL 1X10X0,25G BXL; DENTAL COMPOSITE, RESIN DEVICES, PRODUCT CODE: EBF

Catalog Number 66039026

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Sensitivity of Teeth (2427)

Event Date 02/09/2022

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 office staff reported the patient having an allergic type reaction.The incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.Patient suffered a rash immediately after the venus diamond composite was placed, the patient did not receive anesthetic for this procedure.The composite was removed the same day and the rash subsided within 24 hours.The patient experienced lumps on her lips, blisters and crust on the side of her mouth that subsided in 3 days.The patient was prescribed an antihistamine and an appointment with her general practitioner.An allergy test has not been completed at this time and it is unknown if an allergy test will be conducted.We cannot determine if our product did or did not cause this allergic type reaction, therefore we will report this incident out of an abundance of caution.

Event Description

This event took place in (b)(6).Patient suffered rash after composite filling was placed.No anesthetic was used for this procedure.Composite was removed same day and the rash was gone within 24 hours.The patient experienced lumps on her lips, blisters and crust on the sides of her mouth for 3 days afterwards.The patient was prescribed an antihistamine and an appointment with her general practitioner.An allergy test has not been completed at this time and it is unknown if an allergy test will be conducted.

• Brand Name: VENUS DIAMOND PLT REFILL 1X10X0,25G BXL
• Type of Device: DENTAL COMPOSITE, RESIN DEVICES, PRODUCT CODE: EBF
• Manufacturer (Section D): KULZER, GMBH-HQ; leipziger strasse 2; hanau, hesse, 63450 ; GM 63450
• MDR Report Key: 13695391
• MDR Text Key: 290572488
• Report Number: 1821514-2022-00001
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66039026
• Device Lot Number: K010203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/10/2022
• Device Age: 6 MO
• Event Location: Other
• Date Report to Manufacturer: 03/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other