N
Patient 1
DEVICE NOT MADE AVAILABLE BY CUSTOMER.
MAUDE MDR 9795170
- MDR report key
- 9795170
- Report number
- 0001831750-2020-00308
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-02-12
- Date received
- 2020-03-05
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. KRISTEN CANTER
- Address
- 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US
- Phone
- 269-269-2693
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MX-PRO R-3 AMBULANCE COT | STRETCHER, WHEELED | STRYKER MEDICAL-KALAMAZOO | FPO | 6082 | 6082000000 | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-05 | 0 | 1. O |
Event Narratives#
D
Patient 1
IT WAS REPORTED BY A PATIENT?S ATTORNEY THAT ALLEGEDLY A GURNEY MODEL 6082 FAILED TO PERFORM. IT IS ALLEGED THAT AS A RESULT OF THE EVENT THE PATIENT SUSTAINED BODILY INJURIES. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE ALLEGED MALFUNCTION OR INJURY TO THE PATIENT.