MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-12 for PALAXPRESS, 500ML LIQUID 64710513 manufactured by Kulzer, Gmbh.
| Report Number | 1821514-2019-00007 |
| MDR Report Key | 8692498 |
| Date Received | 2019-06-12 |
| Date of Report | 2019-06-11 |
| Date of Event | 2019-05-09 |
| Date Facility Aware | 2019-05-15 |
| Report Date | 2019-06-11 |
| Date Reported to Mfgr | 2019-06-11 |
| Date Added to Maude | 2019-06-12 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALAXPRESS, 500ML LIQUID |
| Generic Name | DENTURE RELINE MATERIAL |
| Product Code | EBI |
| Date Received | 2019-06-12 |
| Catalog Number | 64710513 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER, GMBH |
| Manufacturer Address | PHILIPP-REIS-STRABE 8/13 WEHRHEIM, D-61273 GM D-61273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2019-06-12 |