MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-18 for PRIDE MOBILITY PRODUCTS Q6 EDGE 3 N/A manufactured by Pride Mobility Products.
Report Number | 2530130-2020-00033 |
MDR Report Key | 9847448 |
Report Source | DISTRIBUTOR |
Date Received | 2020-03-18 |
Date of Report | 2020-03-16 |
Date Mfgr Received | 2020-03-05 |
Device Manufacturer Date | 2019-11-06 |
Date Added to Maude | 2020-03-18 |
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 | MISS KELLY LIVINGSTON |
Manufacturer Street | 401 YORK AVE |
Manufacturer City | DURYEA, PA |
Manufacturer Country | US |
Manufacturer Phone | 6024056 |
Manufacturer G1 | N/A |
Manufacturer Street | N/A N/A |
Manufacturer City | N/A, |
Manufacturer Country | US |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | PRIDE MOBILITY PRODUCTS |
Generic Name | POWERED WHEELCHAIR |
Product Code | ITI |
Date Received | 2020-03-18 |
Model Number | Q6 EDGE 3 |
Catalog Number | N/A |
Lot Number | N/A |
Operator | LAY USER/PATIENT |
Device Availability | Y |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | PRIDE MOBILITY PRODUCTS |
Manufacturer Address | 401 YORK AVE DURYEA, PA US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2020-03-18 |