FDA Adverse Event
Injury
Summary report: N
MICROTARGETING PLATFORM
MDR report key: 1514375
·
Received October 22, 2009
Report
- Report Number
- 3005677147-2009-00004
- Event Type
- Injury
- Date Received
- October 22, 2009
- Date of Event
- September 22, 2009
- Report Date
- October 22, 2009
- Manufacturer
- FHC, INC.
- Product Code
- HAW
- PMA / PMN Number
- K003776
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO FURTHER EVALUATION OF THE PRODUCT IS POSSIBLE. PLANNING FOR THIS PLATFORM BUILD WAS DONE WITHOUT MFR PRESENT AND PLANNING FILES ARE NOT AVAILABLE TO MFR FOR REVIEW. MANUFACTURER REPRESENTATIVE WILL BE PRESENT AT RE-SCHEDULED SURGERY.
Description of Event or Problem · 1
DISTRIBUTOR REPRESENTATIVE REPORTED SURGEON WAS UNCOMFORTABLE WITH THE TRAJECTORY OF A MICROTARGETING PLATFORM BUILT FOR THE SURGERY. PATIENT HAD BEEN PREPPED FOR SURGERY INCLUDING OPENING OF THE BURR HOLE IN THE SKULL. SURGERY WAS SUBSEQUENTLY CANCELLED. SURGERY HAS BEEN RE-SCHEDULED WITH NEW MICROTARGETING PLATFORM. NO FURTHER PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROTARGETING PLATFORM | HAW | FHC, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |