MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-03-24 for POWERED WHEELCHAIR SYSTEM 50T-MAXX manufactured by Motion Concepts Lp.
Report Number | 9615350-2020-00003 |
MDR Report Key | 9873964 |
Report Source | FOREIGN |
Date Received | 2020-03-24 |
Date of Report | 2020-03-24 |
Date of Event | 2018-06-17 |
Device Manufacturer Date | 2016-03-31 |
Date Added to Maude | 2020-03-24 |
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 | 2020-03-24 |
Model Number | 50T-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. Other; 2. Deathisabilit | 2020-03-24 |