MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-13 for POWERED WHEELCHAIR SYSTEM 45T-12L-RESR-MAXX manufactured by Motion Concepts Lp.
[183371921]
The mentioned system was shipped to (b)(4) (motion concepts distributor) on 08-may-2017 & was then sold to (b)(6) on (b)(6) 2017. The dealer stated that the incident is not because of any system malfunction. However, an injury has been involved in this incident so, we consider it as reportable event.
Patient Sequence No: 1, Text Type: N, H10
[183371922]
On 21-feb-2020, motion concepts was notified by (b)(4) (motion concepts importer) that one of their dealers (b)(4 was notified of an incident that took place on (b)(6) 2020. The dealer reported that the system was struck by a public transport while trying to cross the road. Unfortunately, the system was tipped over on its back and the user was knocked out of the system and as per dealer he has unspecified fracture of lumbar vertebra. As of now the user is hospitalized and the dealer stated that the incident is not because of any system malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615350-2020-00002 |
| MDR Report Key | 9828918 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-03 |
| Device Manufacturer Date | 2017-05-08 |
| Date Added to Maude | 2020-03-13 |
| 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 | MS. DONA BHAMRA |
| Manufacturer Street | 84 CITATION DRIVE UNIT 1-12 |
| Manufacturer City | CONCORD, ONTARIO L4K 3C1 |
| Manufacturer Country | CA |
| Manufacturer Postal | L4K 3C1 |
| Manufacturer G1 | MOTION CONCEPTS LP |
| Manufacturer Street | 84 CITATION DRIVE UNIT 1-12 |
| Manufacturer City | CONCORD, ONTARIO L4K 3C1 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | L4K 3C1 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWERED WHEELCHAIR SYSTEM |
| Generic Name | WHEELCHAIR |
| Product Code | ITI |
| Date Received | 2020-03-13 |
| Model Number | 45T-12L-RESR-MAXX |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOTION CONCEPTS LP |
| Manufacturer Address | 84 CITATION DRIVE UNIT 1-12 CONCORD, ONTARIO L4K 3C1 CA L4K 3C1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-13 |