MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2016-07-12 for PALAXPRESS LIQUID 80ML 64711631 manufactured by Heraeus Kulzer Gmbh.
[49367827]
This event occurred in (b)(6). From directions for use: contraindication. Direct lining with palaxpress is contraindicated. If the patient is allergic to one or more ingredients of palaxpress, the product must not be used. To further reduce the risk of intolerance, heraeus kulzer recommends always immersing prostheses (both new and repaired) in tepid water for at least 12 hours before placement. (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, and the patient is non-compliant. Product was not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[49367828]
A dental technician applied palaxpress liquid monomer directly into the patient's mouth. The patient experienced burning feeling, had shortness of breath and vomiting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2016-00011 |
| MDR Report Key | 5787765 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-07-12 |
| Date of Report | 2016-06-23 |
| Date of Event | 2016-06-20 |
| Date Facility Aware | 2016-06-23 |
| Date Mfgr Received | 2016-06-23 |
| Date Added to Maude | 2016-07-12 |
| 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 | PATIENT |
| 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 | PALAXPRESS LIQUID 80ML |
| Generic Name | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
| Product Code | EBI |
| Date Received | 2016-07-12 |
| Catalog Number | 64711631 |
| Operator | HEALTH PROFESSIONAL |
| 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. Required No Informationntervention | 2016-07-12 |