MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-26 for CAREX FGB65877 0000 B658-77 manufactured by Com-da Healthcare Co., Ltd..
| Report Number | 3014644996-2019-00002 |
| MDR Report Key | 9121992 |
| Date Received | 2019-09-26 |
| Date of Report | 2019-09-26 |
| Date of Event | 2019-09-03 |
| Date Mfgr Received | 2019-09-25 |
| Date Added to Maude | 2019-09-26 |
| 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 | KEVIN WALLS |
| Manufacturer Street | 33 GOLDEN EAGLE LANE |
| Manufacturer City | LITTLETON CO 80127 |
| Manufacturer Country | US |
| Manufacturer Postal | 80127 |
| Manufacturer Phone | 7209625412 |
| Manufacturer G1 | COM-DA HEALTHCARE CO., LTD. |
| Manufacturer Street | UNIT 3 NO. 94 DONGCHENG ROAD DONG SHENG TOWN |
| Manufacturer City | ZHONG SHAN CITY, GUANGDONG |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAREX |
| Generic Name | BATH & SHOWER SEAT WITH BACK |
| Product Code | ILS |
| Date Received | 2019-09-26 |
| Model Number | FGB65877 0000 |
| Catalog Number | B658-77 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COM-DA HEALTHCARE CO., LTD. |
| Manufacturer Address | UNIT 3 NO. 94 DONGCHENG ROAD DONG SHENG TOWN ZHONG SHAN CITY, GUANGDONG CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-09-26 |