MAUDE Adverse Event Report: KULZER, GMBH VENUS PEARL PLT REFILL 20X0, 2G A3; DENTAL COMPOSITE, RESIN DEVICES, PRODUCT CODE: EBF

Catalog Number 66048143

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Intraoperative Pain (2662)

Event Date 11/26/2019

Event Type  Injury  

Event Description

This event took place in (b)(6).Root canal treatment after filling treatment-clarification of an allergic reaction.(b)(6) 2019- patient called kulzer for material samples for an allergy testing.She was treated at the beginning of (b)(6) and developed an inflammation.After the treatment she complained about pain for days.The dentist recommended an allergy test, the patient developed inflammation after a former treatment with dyrat, too.Now a root canal treatment is required, which will be performed during the next appointment.The allergy test is probably only carried out if the costs are covered by the health insurance company.Near the patients home town, allergy tests are performed at (b)(6).(b)(6) 2019- phone call with the patient (mrs.(b)(6)).(b)(6) 2019- send evaluation form to the dentist.(b)(6) 2019- send fax again as a reminder.

• Brand Name: VENUS PEARL PLT REFILL 20X0, 2G A3
• Type of Device: DENTAL COMPOSITE, RESIN DEVICES, PRODUCT CODE: EBF
• Manufacturer (Section D): KULZER, GMBH; philipp-reis-strabe 8/13; wehrheim, D-612 73; GM D-61273
• MDR Report Key: 9495079
• MDR Text Key: 188808629
• Report Number: 1821514-2019-00012
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66048143
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/26/2019
• Event Location: Other
• Date Report to Manufacturer: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other