MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for DRIVE RTL10365-ADJ manufactured by Homecare Enterprise Co., Ltd..
| Report Number | 2438477-2020-00019 |
| MDR Report Key | 9884725 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-10-01 |
| Date Facility Aware | 2020-03-10 |
| Report Date | 2020-03-26 |
| Date Reported to FDA | 2020-03-26 |
| Date Reported to Mfgr | 2020-03-27 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE |
| Generic Name | CANE |
| Product Code | IPS |
| Date Received | 2020-03-26 |
| Model Number | RTL10365-ADJ |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 32 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOMECARE ENTERPRISE CO., LTD. |
| Manufacturer Address | NO. 488, LUNMEI ROAD CHANGHUA CITY CHANGHUA,, 50071 TW 50071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-26 |