MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-04-22 for CHARISMA 66000086 manufactured by Heraeus Kulzer Gmbh.
[43435086]
(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 method/results/conclusion- device has not been returned by customer.
Patient Sequence No: 1, Text Type: N, H10
[43435087]
Patient reports vague and diffuse symptoms since having restorations replaced with resin. Allergist recommended resin restorations be replaced with amalgam.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2016-00008 |
| MDR Report Key | 5599469 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-04-22 |
| Date of Report | 2016-04-07 |
| Date of Event | 2015-10-01 |
| Date Facility Aware | 2016-04-07 |
| Date Mfgr Received | 2016-04-07 |
| Date Added to Maude | 2016-04-22 |
| 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 | 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 | CHARISMA |
| Generic Name | MATERIAL, TOOTH SHADE, RESIN |
| Product Code | EBI |
| Date Received | 2016-04-22 |
| Catalog Number | 66000086 |
| 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. Required No Informationntervention | 2016-04-22 |