MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2015-03-25 for PALADUR PINK 64707945 manufactured by Heraeus Kulzer Gmbh.
[21082195]
This incident occurred in (b)(6). Reporting technical service: (b)(6). (b)(6) 2014: telescope prosthesis produced with paladur (patient free of complaints). End of 2014: first of three repairs with paladur were performed and afflictions of the patient began (mucosa irritation of the throat, burning sensation on the tongue). 2015: an allergy test was accomplished: with no result concerning paladur but with an adverse reaction to a so called allergy-free compound sinomer (used due to a good experience of the dental lab with this product). Further planned measure is to remove paladur as far as possible and to replace the base material by paladon. Patient has never seen an allergist. Obviously, a dental technician did this "allergy testing" on its own; he did this test to compare paladur with sinomer (novodent - methyl methacrylate free product). By now the patient's afflictions and the causation for them are still unclear and further information has to be required from the lab and a regular allergy test is recommended. We recommended to work together with an allergist and will send the compound information if a contact is given. Additionally, an alloy allergy should be considered as it is a telescopic work with metal parts which could be the cause for the symptoms, too (see negative result of the unqualified allergy testing). This is reportable according to 21 cfr 803. There is an allegation of serious injury as defined in part 803. 3. The patient involved is investigating a potential allergic reaction. No accusation or proof has been given that this device caused or contributed to the patients symptoms. Out of an abundance of caution we will report this incident. Although this exact product is not available in north america, it is substantially equivalent to palapress and palaxpress which are available in north america.
Patient Sequence No: 1, Text Type: D, B5
[21514205]
(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. Method/results/conclusion: device has not been returned by customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610902-2015-00006 |
| MDR Report Key | 4630195 |
| Report Source | 01,07 |
| Date Received | 2015-03-25 |
| Date of Report | 2015-03-06 |
| Date of Event | 2014-12-01 |
| Date Facility Aware | 2015-03-06 |
| Date Mfgr Received | 2015-03-06 |
| Date Added to Maude | 2015-03-25 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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, LLC |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614251 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46614 2517 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALADUR PINK |
| Generic Name | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
| Product Code | EBI |
| Date Received | 2015-03-25 |
| Catalog Number | 64707945 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2015-03-25 |