MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-21 for SMR -REVERSE RESECTION JIG DPA 9013.52.304 manufactured by Limacorporate S.p.a..
| Report Number | 3008021110-2020-00003 |
| MDR Report Key | 9611202 |
| Report Source | OTHER |
| Date Received | 2020-01-21 |
| Date of Event | 2020-01-15 |
| Date Added to Maude | 2020-01-21 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Country | IT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMR -REVERSE RESECTION JIG DPA |
| Generic Name | REVERSE RESECTION JIG - DELTOPECTORAL APPROACH (KWT, HSD) |
| Product Code | KWT |
| Date Received | 2020-01-21 |
| Model Number | 9013.52.304 |
| Lot Number | 15AQ01C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIMACORPORATE S.P.A. |
| Manufacturer Address | VIA NAZIONALE 52 VILLANOVA DI SAN DANIELE, 33038 IT 33038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-21 |