MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-09 for !M1 manufactured by Solutions For Tomorrow Ab.
| Report Number | 3013677815-2020-00001 |
| MDR Report Key | 9805187 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2018-09-28 |
| Date Added to Maude | 2020-03-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS ELISABETH LUNDAHL |
| Manufacturer Street | SAXAG |
| Manufacturer City | V 36251 |
| Manufacturer Country | SW |
| Manufacturer Postal | 36251 |
| Manufacturer G1 | SOLUTIONS FOR TOMORROW AB |
| Manufacturer Street | SAXAG |
| Manufacturer City | V 36251 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 36251 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | !M1 |
| Generic Name | !M1 MODELONE |
| Product Code | IZL |
| Date Received | 2020-03-09 |
| Returned To Mfg | 2020-02-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOLUTIONS FOR TOMORROW AB |
| Manufacturer Address | SAXAG?RDSV?GEN 5 V?CKELS?NG, KRONOBERG 36251 SW 36251 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-09 |