D
Patient 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE FOOTREST WOULD NOT REMAIN OPEN, AND WAS COLLAPSING, DUE TO A BENT MECHANISM. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
MAUDE MDR 6746683
- MDR report key
- 6746683
- Report number
- 0001831750-2017-00316
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-06-28
- Date received
- 2017-07-27
- 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 | TREATMENT RECLINER | CHAIR, EXAMINATION AND TREATMENT | STRYKER MEDICAL-KALAMAZOO | FRK | 3500000710 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-07-27 | 0 |
Event Narratives#
N
Patient 1
D
Patient 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE FOOTREST WOULD NOT REMAIN OPEN, AND WAS COLLAPSING, DUE TO A BENT MECHANISM. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
N
Patient 1
SUPPLEMENTAL SUBMITTED TO INCLUDE UDI.
D
Patient 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE FOOTREST WOULD NOT REMAIN OPEN, AND WAS COLLAPSING, DUE TO A BENT MECHANISM. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.