MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-10-17 for SCALAMOBIL S39 EU:1521110 manufactured by Alber Gmbh.
| Report Number | 3004730072-2019-00007 |
| MDR Report Key | 9201014 |
| Report Source | OTHER |
| Date Received | 2019-10-17 |
| Date of Report | 2019-09-25 |
| Date of Event | 2019-09-06 |
| Date Mfgr Received | 2019-09-25 |
| Device Manufacturer Date | 2018-04-13 |
| Date Added to Maude | 2019-10-17 |
| 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. CHRISTOPH HAUSCHEL |
| Manufacturer Street | VOR DEM WEISSEN STEIN 21 |
| Manufacturer City | ALBSTADT, BADEN-W 72461 |
| Manufacturer Country | GM |
| Manufacturer Postal | 72461 |
| Manufacturer G1 | ALBER GMBH |
| Manufacturer Street | VOR DEM WEISSEN STEIN 21 |
| Manufacturer City | ALBSTADT, BADEN-W 72461 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 72461 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCALAMOBIL S39 |
| Generic Name | SCALAMOBIL |
| Product Code | ING |
| Date Received | 2019-10-17 |
| Returned To Mfg | 2019-10-04 |
| Model Number | EU:1521110 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALBER GMBH |
| Manufacturer Address | VOR DEM WEISSEN STEIN 21 ALBSTADT, BADEN-W?RTTEMBERG, GERMANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-10-17 |