MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-08-22 for VENUS COMPOSITE 66007981 manufactured by Kulzer, Llc.
[83294311]
(b)(4). Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution. Narrative-device has not been returned and lot number is not known. Analysis of directions for use state: the use of this product is contraindicated in case of known or suspected allergies against (meth)acrylate compounds.
Patient Sequence No: 1, Text Type: N, H10
[83294312]
This occurred in (b)(6). A (b)(6) year old female had composite filling done in (b)(6), was fine when she left the practice, but at some point (not known) went to her gp complaining of a reaction to something, and the gp requested a list of ingredients of this product. Type of reaction the patient had is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2017-00013 |
| MDR Report Key | 6811177 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-08-22 |
| Date of Report | 2017-08-17 |
| Date of Event | 2017-02-01 |
| Date Facility Aware | 2017-08-17 |
| Date Mfgr Received | 2017-08-17 |
| Date Added to Maude | 2017-08-22 |
| 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. RITA ROGERS |
| Manufacturer Street | 4315 SOUTH LAFAYETTE BLVD. |
| Manufacturer City | SOUTH BEND 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer G1 | KULZER, LLC |
| Manufacturer Street | PHILIPP-REIS-STRASSE 8/13 |
| Manufacturer City | WEHRHEIM, HESSEN 61273 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 61273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENUS COMPOSITE |
| Generic Name | MATERIAL, TOOTH SHADE, RESIN |
| Product Code | EBF |
| Date Received | 2017-08-22 |
| Catalog Number | 66007981 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER, LLC |
| Manufacturer Address | PHILIPP-REIS-STRASSE 8/13 WEHRHEIM, HESSEN 61273 GM 61273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-22 |