MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-18 for OMNISTIM 500 PRO 100500C manufactured by Accelerated Care Plus Corp.
| Report Number | 8707008 |
| MDR Report Key | 8707008 |
| Date Received | 2019-06-18 |
| Date of Report | 2019-06-14 |
| Date of Event | 2019-03-28 |
| Report Date | 2019-06-14 |
| Date Reported to FDA | 2019-06-14 |
| Date Reported to Mfgr | 2019-06-18 |
| Date Added to Maude | 2019-06-18 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| 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 | OMNISTIM 500 PRO |
| Generic Name | STIMULATOR, MUSCLE, POWERED |
| Product Code | IPF |
| Date Received | 2019-06-18 |
| Model Number | 100500C |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCELERATED CARE PLUS CORP |
| Manufacturer Address | 4999 AIRCENTER CIR. STE 103 RENO NV 89502 US 89502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-06-18 |