D
Patient 1
IT WAS REPORTED THAT WHEN EXPOSING THE CORE SAMPLE THE GUN WOULD NOT CLOCK BACK UP AND MISFIRED. THIS HAPPENED TO EIGHT DIFFERENT DEVICES. THERE WAS NO PATIENT IMPACT.
MAUDE MDR 4196606
- MDR report key
- 4196606
- Report number
- 1018233-2014-00284
- Event key
- 0
- Event type
- 3
- Date received
- 2014-10-17
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- CHRSITY LEWIS
- Address
- 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US
- Phone
- 770-770-7707
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MAXCORE DISPOSABLE BIOPSY SYSTEM | BARD REYNOSA S.A. DE C.V. | KNW | NA | MC1820 | REYC2853 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-10-17 | 0 |
Event Narratives#
N
Patient 1
INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.