MAUDE Adverse Event Report: HERAEUS KULZER GMBH VENUS PEARL SYRINGE REFILL; MATERIAL, TOOTH SHADE, RESIN

Catalog Number 66048176

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

Patient Problem Swelling (2091)

Event Type  Injury  

Event Description

Dental assistant called for ingredient list of venus pearl.Has female, (b)(6) patient who suspects she is allergic to composite fillings.Patient has had venus pearl a2 restorations placed starting several years ago and experiences swelling for 2-3 days after dental appointments.Patient takes benadryl before and after her restorative appointments and has visited md for this problem.Patient stated that if she does not take benadryl she looks like "elephant man".Dental assistant is not convinced the patient is allergic to venus pearl, but wants to help the patient and her physician rule out the possibility.I recommended dental assistant provide the patient with a sample so that she may be tested at by an allergist.Emailed venus chemistry difference.Pdf to office email.This incident is reportable according to 21 cfr 803.The fda defines this as a serious injury (21 cfr sec.803.3) as the dentist reported patients having adverse reaction.Because the malfunction allegation could not be confirmed, the cause of the adverse reaction could not be determined.The incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.

Manufacturer Narrative

(b)(4).This incident is reportable according to 21 cfr 803.The fda defines this as a serious injury (21 cfr sec.803.3) as the dentist reported patient having adverse reaction.Because the malfunction allegation could not be confirmed, the cause of the adverse reaction could not be determined.The incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.Device has not been returned by customer.

• Brand Name: VENUS PEARL SYRINGE REFILL
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): HERAEUS KULZER GMBH; philipp-reis-strasse 8/13; wehrheim, D-61 273; GM D-61273
• Manufacturer (Section G): HERAEUS KULZER GMBH; philipp-reis-strasse 8/13; wehrheim, D-61 273; GM D-61273
• Manufacturer Contact: rita rogers ; 300 heraeus way; south bend, IN 46614 ; 5742995409
• MDR Report Key: 4699142
• MDR Text Key: 17211983
• Report Number: 9610902-2015-00007
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dental Assistant
• Type of Report: Initial
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 66048176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/06/2015
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR