MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-30 for DORNIER COMPACT SIGMA K1025660 manufactured by Dornier Medtech Systems Gmbh.
| Report Number | 1037955-2019-00037 |
| MDR Report Key | 8843346 |
| Date Received | 2019-07-30 |
| Date of Report | 2019-07-26 |
| Date of Event | 2019-07-26 |
| Date Facility Aware | 2019-07-26 |
| Report Date | 2019-07-30 |
| Date Reported to Mfgr | 2019-07-30 |
| Date Added to Maude | 2019-07-30 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | DORNIER COMPACT SIGMA |
| Generic Name | LITHOTRIPTER |
| Product Code | LNS |
| Date Received | 2019-07-30 |
| Model Number | COMPACT SIGMA |
| Catalog Number | K1025660 |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DORNIER MEDTECH SYSTEMS GMBH |
| Manufacturer Address | ARGELSRIEDER FELD 7 WESSLING, BAVARIA D-82234 GM D-82234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-30 |