MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-12-01 for PALADON 65 64707687 manufactured by Heraeus Kulzer Gmbh.
[61199800]
This event occurred in (b)(6). From directions for use: advice: product contains monomers (e. G. Methacrylates) which may cause skin allergies, especially with sensitive patients. For patients with a resin allergy or when allergic reactions are observed, the product is contraindicated. (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 by customer. Lot number unknown, no return.
Patient Sequence No: 1, Text Type: N, H10
[61199801]
Patient has a muscosal intolerance after getting a prosthesis made of paladon 65.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2016-00019 |
| MDR Report Key | 6137752 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-12-01 |
| Date of Report | 2016-11-04 |
| Date Facility Aware | 2016-11-04 |
| Date Mfgr Received | 2016-11-04 |
| Date Added to Maude | 2016-12-01 |
| 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 | 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 | PALADON 65 |
| Generic Name | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
| Product Code | EBI |
| Date Received | 2016-12-01 |
| Catalog Number | 64707687 |
| 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 | 2016-12-01 |