MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-10-02 for DORNIER DELTA III K1039062 manufactured by Dornier Medtech Systems Gmbh.
| Report Number | 9611388-2019-00007 |
| MDR Report Key | 9144258 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-10-02 |
| Date of Report | 2019-09-10 |
| Date of Event | 2019-09-05 |
| Date Mfgr Received | 2019-09-10 |
| Device Manufacturer Date | 2019-03-14 |
| Date Added to Maude | 2019-10-02 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JENS REHDER |
| Manufacturer Street | ARGELSRIEDER FELD 7 WESSLING, BAVARIA D-82234, GM |
| Manufacturer City | WESSLING, BAVARIA D-82234 |
| Manufacturer Country | GM |
| Manufacturer Postal | D-82234 |
| Manufacturer G1 | DORNIER MEDTECH SYSTEMS GMBH |
| Manufacturer Street | ARGELSRIEDER FELD 7 |
| Manufacturer City | WESSLING, D-82234 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-82234 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DORNIER DELTA III |
| Generic Name | LITHOTRIPTER, PRODUCT CODE: LNS |
| Product Code | LNS |
| Date Received | 2019-10-02 |
| Model Number | DORNIER DELTA III |
| Catalog Number | K1039062 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DORNIER MEDTECH SYSTEMS GMBH |
| Manufacturer Address | ARGELSRIEDER FELD 7 WESSLING, BAVARIA D-82234, GM WESSLING, D-82234 GM D-82234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-02 |