MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2015-01-13 for PALXPRESS 66043319 manufactured by Heraeus Kulzer Gmbh.
[5372671]
Heraeus kulzer (b)(4) reports potential allergic reaction two years after dentures were manufactured using (b)(4). Laboratory of solta-dent dental laboratory has obtained the exact composition of our product of palaxpress. After sending (b)(4) has asked for recall with the zap (b)(4). In the phone call with (b)(4) turned out, that patient has a reaction to their uk and ok - prosthesis. It highlights mucosal changes - white ich, red sores. The dentures were made in the years 2012 - since then the positions are available. After a lining of the uk - prosthesis in may of this year with palaxpress clear these places have disappeared. The ok - graft next year should also be colorless relined. I told the customer to refer the patient to an allergist before they relined the ok or to keep me on this case on the current. If it's allergy only color pigments can be the trigger. This incident occurred in (b)(6). 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. Report to fda due to product being substantially equivalent to product available for purchase in north america.
Patient Sequence No: 1, Text Type: D, B5
[12758263]
(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. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610902-2015-00001 |
| MDR Report Key | 4414114 |
| Report Source | 01,07 |
| Date Received | 2015-01-13 |
| Date of Report | 2015-12-15 |
| Date Facility Aware | 2015-01-08 |
| Date Mfgr Received | 2015-12-15 |
| Date Added to Maude | 2015-01-13 |
| 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 GMBH |
| Manufacturer Street | PHILIPP-REIS-STRASSE 8/13 |
| Manufacturer City | WEHRHEIM, D-61273 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-61273 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALXPRESS |
| Generic Name | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
| Product Code | EBI |
| Date Received | 2015-01-13 |
| Catalog Number | 66043319 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-01-13 |