MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-11 for RICHMAR 400-080 manufactured by Compass Health Brands.
| Report Number | 3012316249-2019-00038 |
| MDR Report Key | 9304482 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-11-11 |
| Date of Report | 2019-11-11 |
| Date of Event | 2019-10-17 |
| Date Mfgr Received | 2019-10-17 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2019-11-11 |
| 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 | CYNTHIA TONEY |
| Manufacturer Street | 6753 ENGLE ROAD |
| Manufacturer City | MIDDLEBURG HEIGHTS 44130 |
| Manufacturer Country | US |
| Manufacturer Postal | 44130 |
| Manufacturer Phone | 4402682110 |
| Manufacturer G1 | COMPASS HEALTH BRANDS |
| Manufacturer Street | 6753 ENGLE ROAD |
| Manufacturer City | MIDDLEBURG HEIGHTS 44130 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RICHMAR |
| Generic Name | THERATOUCH 7.7S |
| Product Code | GZJ |
| Date Received | 2019-11-11 |
| Model Number | 400-080 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COMPASS HEALTH BRANDS |
| Manufacturer Address | 6753 ENGLE ROAD MIDDLEBURG HEIGHTS 44130 US 44130 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-11 |