MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-03-23 for VENUS DIAMOND 66048141 manufactured by Heraeus Kulzer Gmbh.
[70689792]
Patient stated at last correspondence that she actually began to have the stated symptoms after a composite material by (b)(4) was used a year ago and after the recent restoration was completed with venus diamond, the symptoms became more pronounced. Our facility recommended that patient send the treating dentist a copy of the biocompatibility report and go for a follow up visit. (b)(4). The direction for use state: do not use in cases of a known allergy to any of the constituents of venus diamond. The use of this product is contraindicated in case of known of suspected allergies against (meth)acrylate compounds. This product or one of its components may in particular cases cause hypersensitive reactions. Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21cfr part 803 and out of an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[70689793]
Patient had a filling placed and a couple of days later she began having arthritic like symptoms. She is having pain throughout her body. She had not contacted her dds office. The patient did take the initiative to have a biocompatibility study conducted. The dental office confirmed that the patient had a restoration placed in september of 2016 with venus diamond composite material. The office had not been contacted by the patient at that time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2017-00006 |
| MDR Report Key | 6427827 |
| Report Source | CONSUMER |
| Date Received | 2017-03-23 |
| Date of Report | 2017-03-21 |
| Date of Event | 2016-09-01 |
| Date Facility Aware | 2017-02-23 |
| Date Mfgr Received | 2017-02-23 |
| Date Added to Maude | 2017-03-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. AMBER BROWN |
| Manufacturer Street | 4315 LAFAYETTE BLVD. |
| Manufacturer City | SOUTH BEND IN 466142517 |
| Manufacturer Country | US |
| Manufacturer Postal | 466142517 |
| Manufacturer Phone | 5742995411 |
| Manufacturer G1 | HERAEUS KULZER GMBH |
| Manufacturer Street | PHILIP-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 | DENTAL COMPOSITE/RESIN |
| Product Code | EBF |
| Date Received | 2017-03-23 |
| Catalog Number | 66048141 |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER GMBH |
| Manufacturer Address | PHILIP-REIS-STRABE 8/13 WEHRHEIM, D-61273 GM D-61273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-23 |