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

Catalog Number 66048143

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994)

Event Date 11/26/2019

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.Allergy testing may or may not be conducted.At this time, we cannot rule out our product being the cause of contributing to the patients allergic reaction.Due to this, the incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.Nevertheless, as manufacturer we are familiar with treatment issues following the filling therapy and causing post-op sensitivity until tissue inflammation and in rare cases root canal treatments.The root cause is often the treatment procedure depending on the depth of cavity and hygiene and cleanliness during excavation and filling procedure.

Event Description

This event took place in (b)(6).Root canal treatment after a filling therapy; patient compound request for clarification of an allergic reaction as root cause for the root canal treatment.On (b)(6) 2019- patient called kulzer for material samples for an allergy testing.She was treated beginning of (b)(6) with venus pearl as restorative composite.She developed an inflammation.After the treatment she complained about post-op sensitivity and pain for days.The dentist recommended an allergy test.Now a root canal treatment is required according to the dentist.This will be done at next appointment.Patient will perform the allergy testing only if the costs are covered by the health insurance company.The allergy testing can be performed near to the patients home town.There is a recommendation for the dermatology center of the university medical center of (b)(6).If kulzer will get a confirmation that the root canal is a consequence of an allergy to the filling therapy with venus pearl is doubtful and questionable.A general risk of a filling therapy is post-op sensitivity and an inflammation of the tooth tissue due to excavation near to the pulp and microbial contamination of the cavity during the treatment.An allergic reaction as root cause for the follow-up treatment is at least likely.On (b)(6) 2019 - phone call with the patient (mrs.(b)(6)); on (b)(6) 2019 - sending an evaluation form for the event to the dentist.; on (b)(6) 2019 - sending a fax reminder to the dentist as reminder to fill the evaluation form.

• Brand Name: VENUS PEARL PLT REFILL 20X0, 2G A3
• Type of Device: DENTAL COMPOSITE, RESIN DEVICES
• Manufacturer (Section D): KULZER GMBH - HQ; leipziger strasse 2; hanau, 63450 ; GM 63450
• Manufacturer (Section G): KULZER GMBH - KDEW; philipp-reis-strasse 8/13; wehrheim, 61273 ; GM 61273
• Manufacturer Contact: albert erdrich ; leipziger strasse 2; hanau, 63450 ; GM 63450
• MDR Report Key: 9502435
• MDR Text Key: 183309818
• Report Number: 9610902-2019-00011
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• 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
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other