MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-23 for DRIVE 795B manufactured by Max Health.
[60845376]
Drive devilbiss healthcare received notification of an incident involving a duet rollator/transport chair that drive imports and distributes. The patient was using the product in the transport chair setting while being pushed by her caregiver. The patient went over the space between two sidewalk slabs, when allegedly the unit tipped over. She was taken to a nearby urgent care facility where they placed a knee brace on her and treated her for some cuts on her face. Patient is keeping the unit for now since no apparent defect or malfunction was observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2016-00059 |
| MDR Report Key | 6126023 |
| Date Received | 2016-11-23 |
| Date of Report | 2016-10-28 |
| Date of Event | 2016-10-14 |
| Date Facility Aware | 2016-10-28 |
| Report Date | 2016-11-23 |
| Date Reported to FDA | 2016-11-23 |
| Date Reported to Mfgr | 2016-11-23 |
| Date Added to Maude | 2016-11-23 |
| 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 | TRANSPORT/ ROLLATOR CHAIR |
| Product Code | INM |
| Date Received | 2016-11-23 |
| Model Number | 795B |
| Operator | NURSING ASSISTANT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAX HEALTH |
| Manufacturer Address | 15F-6 NO. 81 HSIN TAI WU RD. SEC. 1 HSI CHIH DIST. NEW TAIPEI CITY, TAIPEI HSIEN TW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly; 2. Hospitalization | 2016-11-23 |