MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for DRIVE RTL10266BK manufactured by Chang Cheng Fa Enterprise Co., Limited.
[178307575]
Drive devilbiss healthcare is the initial importer of the device which is a rollator. The unit has not been returned for evaluation. The seat broker while crossing the street. The user hit his head and received medical attention and therapy. Device is not meant to be a transport device. Hangtag notes "do not move rollator while seated. The brakes must remain locked" while seated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2020-00008 |
| MDR Report Key | 9673022 |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-03 |
| Date Facility Aware | 2020-01-03 |
| Report Date | 2020-02-05 |
| Date Reported to FDA | 2020-02-05 |
| Date Reported to Mfgr | 2020-02-06 |
| Date Added to Maude | 2020-02-05 |
| 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 | ROLLATOR |
| Product Code | ITJ |
| Date Received | 2020-02-05 |
| Model Number | RTL10266BK |
| Catalog Number | RTL10266BK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 40 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHANG CHENG FA ENTERPRISE CO., LIMITED |
| Manufacturer Address | 1 BEEN TING, BEEN-TSUOH VILAGE CHIA-YI SHIANN SHI-KOOU SHIANG CHIAYI - DISTR, TW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-02-05 |