D
Patient 1
IT WAS REPORTED THAT THE BRAKES WERE NOT WORKING. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
MAUDE MDR 7889997
- MDR report key
- 7889997
- Report number
- 0001831750-2018-01037
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-08-23
- Date received
- 2018-09-19
- 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. BRIAN THOMPSON
- 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 | PRIME TC SWING-AWAY MODEL | CHAIR, ADJUSTABLE, MECHANICAL | STRYKER MEDICAL-KALAMAZOO | INN | 1460000000 | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-09-19 | 0 |
Event Narratives#
N
Patient 1
THE CUSTOMER REQUESTED A QUOTE FOR REPAIR VS PURCHASING A NEW PRIME TC. THE CUSTOMER THEN DECIDED TO PURCHASE A NEW PRIME TC INSTEAD OF A VISUAL AND FUNCTIONAL INSPECTION AND REPAIR. THEREFORE, A VISUAL AND FUNCTIONAL INSPECTION HAS NOT BEEN PERFORMED BY A STRYKER FIELD SERVICE TECHNICIAN. THE CUSTOMER CANCELED THE EVALUATION.
D
Patient 1
IT WAS REPORTED THAT THE BRAKES WERE NOT WORKING. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.