N
Patient 1
THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR EVALUATION AT THIS TIME. SHOULD THE DEVICE OR FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL THEN BE ISSUED.
MAUDE MDR 9670517
- MDR report key
- 9670517
- Report number
- 2530130-2020-00017
- Event key
- 0
- Event type
- 3
- Date received
- 2020-02-05
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MISS KELLY LIVINGSTON
- Address
- 401 YORK AVE DURYEA PA 18642 US
- Phone
- 570-570-5706
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PRIDE MOBILITY PRODUCTS | POWERED WHEELCHAIR | PRIDE MOBILITY PRODUCTS | ITI | JAZZY SELECT ELITE | N/A | N/A | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-02-05 | 0 | 1. H |
Event Narratives#
D
Patient 1
TECH WAS AT CONSUMER'S FOR A PREVIOUS ISSUE WHEN CONSUMER TOLD TECH THAT HIS CHAIR ALLEGEDLY TIPPED BACKWARDS WHILE GOING UP A STEEP RAMP.