MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-07 for DIMA PRINT ORTHO 66069096 manufactured by Kulzer Gmbh.
| Report Number | 1821514-2019-00011 |
| MDR Report Key | 8871394 |
| Date Received | 2019-08-07 |
| Date of Report | 2019-08-06 |
| Date of Event | 2019-07-12 |
| Date Facility Aware | 2019-07-12 |
| Report Date | 2019-08-07 |
| Date Reported to Mfgr | 2019-08-07 |
| Date Added to Maude | 2019-08-07 |
| 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 | DIMA PRINT ORTHO |
| Generic Name | MAINTAINER, SPACE PREFORMED, ORTHODONTIC |
| Product Code | DYT |
| Date Received | 2019-08-07 |
| Catalog Number | 66069096 |
| Lot Number | XG032N01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER GMBH |
| Manufacturer Address | LEIPZIGER STRABE 2 HANAU, 63450 GM 63450 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-07 |