MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-06-27 for VENUS DIAMOND 66035474 manufactured by Heraeus Kulzer Gmbh.
[78545954]
(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. Not returned, no lot number.
Patient Sequence No: 1, Text Type: N, H10
[78545955]
Male patient has vague allergy symptoms since having dental work done in 2016. Undergoing allergy tests.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2017-00009 |
| MDR Report Key | 6671757 |
| Report Source | CONSUMER |
| Date Received | 2017-06-27 |
| Date of Report | 2017-06-07 |
| Date of Event | 2016-03-07 |
| Date Facility Aware | 2017-06-07 |
| Date Mfgr Received | 2017-06-07 |
| Date Added to Maude | 2017-06-27 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. RITA ROGERS |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995409 |
| Manufacturer G1 | HERAEUS KULZER GMBH |
| Manufacturer Street | PHILIPP-REIS-STRASSE 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 | MATERIAL, TOOTH SHADE, RESIN |
| Product Code | EBF |
| Date Received | 2017-06-27 |
| Catalog Number | 66035474 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER GMBH |
| Manufacturer Address | PHILIPP-REIS-STRASSE 8/13 WEHRHEIM, D-61273 GM D-61273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-06-27 |