MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-28 for VENUS DIAMOND PLT REFILL, SHADE A3 66039011 manufactured by Kulzer Gmbh.
[140192038]
Patient allergy testing indicated an allergy to methacrylate. Venus diamond composite does contain methacrylate compounds. Based on the allergy test results, dentist replaced the restoration with a glass ionomer cement as a permanent solution. We recommend that in patients with a suspected allergy to the product or information in the history of hypersensitivity to any (dental) materials should undergo an allergy test on the product before use. In patients with known allergies to one or more ingredients of the product (allergy pass), similar substances in the same class of substances or dental products it can not be excluded that undesirable side effects in individual cases may occur. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[140192039]
Patient had a composite filling done using venus diamond and had post op sensitivity that did not resolve. Patient had several allergy tests performed by a dermatologist and it was indicated the patient had an allergy to methacrylate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2019-00002 |
| MDR Report Key | 8460701 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-28 |
| Date of Report | 2019-01-21 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-01-21 |
| Date Added to Maude | 2019-03-28 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 PLT REFILL, SHADE A3 |
| Generic Name | COMPOSITE RESIN |
| Product Code | EBF |
| Date Received | 2019-03-28 |
| Catalog Number | 66039011 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-03-28 |