MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2012-11-19 for PALAXPRESS ULTRA POWDER AND LIQUID PINK 66034252 manufactured by Heraeus Kulzer Gmbh.
[2997390]
On (b)(6) 2012 we were informed that palaxpress ultra was used to produce the denture for a pt. Fourteen days after wearing it the pt experienced redness and blisters of the mucosa. The denture was stored in water and the status of the dentist is monitoring the pt's health. On (b)(6) 2012 we were informed that the pt was referred to the hospital. The dental lab stated there is no connection between the denture and the referral to the hospital. On (b)(6) 2012 hk product safety manager spoke to the dentist and was informed that the pt is back at home. The dentist was not clear if the denture and the referral to the hospital are connected. The pt is now wearing her old denture. The dentist will get in touch with hkg if the pt status would change/get worse. On (b)(6) 2012 safety manager spoke to the dentist. The dentist said that the complete maxillary denture made out of palaxpress ultra was delivered to the pt in the middle of (b)(6) 2012. About one week later the pt experienced swelling of the face and increased number of leukocytes. The pt spent a few days in the hospital for treatment. The denture was worn until (b)(6) and then exchanged for the old one. The health situation of the pt has been improved since then, but the symptoms have not completely resolved. The pt receives out-patient treatment by several doctors, but not at the dentist's office. The dentist could not provide any info on the medical treatment of the pt, because he is not involved in the process. The palaxpress ultra denture will be reintroduced to the pt when the pt has recovered completely from the symptoms. We will continue to monitor the pt's recovery.
Patient Sequence No: 1, Text Type: D, B5
[10262567]
As allowed by (b)(4), (the importer) is submitting the report on behalf of heraeus kulzer (b)(4) (the manufacturer). Although we have not established that the device caused or contributed to the event, we're reporting it out of caution to be compliant with 21 cfr part 803. Conclusion - the directions for use gives the following warning, "product contains polymerized monomers (e. G. Methacrylates/acrylates), which may irritate the skin. If any irritation appears or known allergies exist with resins based on methacrylates or acrylates, the product should not be used. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681707-2012-00010 |
| MDR Report Key | 2851331 |
| Report Source | 01,05,07 |
| Date Received | 2012-11-19 |
| Date of Report | 2012-10-24 |
| Date of Event | 2012-09-22 |
| Date Facility Aware | 2012-10-29 |
| Report Date | 2012-10-24 |
| Date Mfgr Received | 2012-10-24 |
| Date Added to Maude | 2012-11-30 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | AUDI BOGUCKI, RDH |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742295409 |
| Manufacturer G1 | HERAEUS KULZER GMBH |
| Manufacturer Street | ALTE HEERSTRASSE B 802 |
| Manufacturer City | DORMAGEN 41538 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 41538 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALAXPRESS ULTRA POWDER AND LIQUID |
| Generic Name | EBI RESIN, DENTURE, RELINING, REPAIRING |
| Product Code | EBI |
| Date Received | 2012-11-19 |
| Model Number | PINK |
| Catalog Number | 66034252 |
| Lot Number | 012063 |
| Device Expiration Date | 2015-05-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER GMBH |
| Manufacturer Address | DORMAGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-11-19 |