D
Patient 1
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
MAUDE MDR 9902964
- MDR report key
- 9902964
- Report number
- 0001811755-2020-00819
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-02
- Date received
- 2020-03-31
- 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. ZACH BAKER
- Address
- 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 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 | SD/PD SERIES XL STRAIGHT ATTACHMENT | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | STRYKER INSTRUMENTS-KALAMAZOO | ERL | 5100120480 | 5100120480 | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |