MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-26 for VENUS DIAMOND 66039015 manufactured by Kulzer Gmbh.
[139820066]
The allergy testing that was conducted, concluded that the patient tested negative for (meth) acrylate compound allergies. However, the test did not include tcd-di-hea. Per the global safety manager of kulzer, it is very likely that with the patient having negative reactions to the afore mentioned (meth) acrylates, this is likely also true for the tcd-di-hea. However likely this may be, it cannot concretely rule out that the symptoms experienced were not cause by the venus diamond composite or the composite material did not contribute to the patient reaction. This incident is being reported out of an abundance of caution and to maintain compliance with 21 cfr 803. (b)(4). This incident occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[139820067]
Patient experienced strong burning sensation in the mouth. She also reported dryness of the mouth and stated the use of artificial saliva provides relief from the symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2019-00003 |
| MDR Report Key | 8451395 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-26 |
| Date of Report | 2019-03-20 |
| Date Mfgr Received | 2019-02-19 |
| Date Added to Maude | 2019-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS AMBER BROWN |
| Manufacturer Street | 4315 S. LAFAYETTE BLVD |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5472995411 |
| Manufacturer G1 | KULZER GMBH |
| Manufacturer Street | PHILIPP-REIS-STRABE 8/13 |
| Manufacturer City | WEHRHEIM, D-61273 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-61273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENUS DIAMOND |
| Generic Name | COMPOSITE RESIN |
| Product Code | EBF |
| Date Received | 2019-03-26 |
| Catalog Number | 66039015 |
| Lot Number | K010040 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 20 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER GMBH |
| Manufacturer Address | PHILIPP-REIS-STRABE 8/13 WEHRHEIM, D-61273 GM D-61273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-26 |