MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-18 for MEDX MBM 1100 CONSOLE SYSTEM MBM1100 900-0108-1101 manufactured by Medx Health Corp.
| Report Number | 3003725190-2019-00001 |
| MDR Report Key | 9084237 |
| Date Received | 2019-09-18 |
| Date of Report | 2019-07-25 |
| Date of Event | 2019-07-02 |
| Date Mfgr Received | 2019-07-25 |
| Device Manufacturer Date | 2007-11-05 |
| Date Added to Maude | 2019-09-18 |
| 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 | ROY TOBILLO |
| Manufacturer Street | 1495 BONHILL ROAD, UNIT #1 |
| Manufacturer City | MISSISSAUGA, ONTARIO L5T1M2 |
| Manufacturer Country | CA |
| Manufacturer Postal | L5T1M2 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDX MBM 1100 CONSOLE SYSTEM |
| Generic Name | REHAB CONSOLE SYSTEM |
| Product Code | ILY |
| Date Received | 2019-09-18 |
| Returned To Mfg | 2019-08-01 |
| Model Number | MBM1100 |
| Catalog Number | 900-0108-1101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDX HEALTH CORP |
| Manufacturer Address | 1495 BONHILL ROAD UNIT #1 MISSISSAUGA, L5T 1M2 CA L5T 1M2 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-18 |