D
Patient 1
PRODUCT FAILED TO PERFORM ONCE PLACED INSIDE OF URETER. THE DEVICE FAILED TO CLOSE ONCE SPECIMEN WAS OBTAINED. PRODUCT WAS REMOVED FROM FIELD.
MAUDE MDR 3364058
- MDR report key
- 3364058
- Report number
- 3364058
- Event key
- 0
- Event type
- 3
- Date of event
- 2013-09-03
- Date received
- 2013-09-11
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 500
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PIRANHA | FORCEPS, BIOPSY | BOSTON SCIENTIFIC | KOA | 505-160 | * | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-09-11 | 0 |