D
Patient 1
CUSTOMER STATES THE LANCET DOES NOT RETRACT INTO THE MULTICLIX LANCET DEVICE AFTER FIRING. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT. INFORMATION NOT PROVIDED FOR WHERE ISSUE WAS DISCOVERED.
MAUDE MDR 852735
- MDR report key
- 852735
- Report number
- 1823260-2007-01946
- Event key
- 0
- Event type
- 3
- Date of event
- 2007-02-17
- Date received
- 2007-03-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 305
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- FERN DELACROIX
- Address
- 9115 HAGUE RD. INDIANAPOLIS IN 46250 US
- Phone
- 925-925-9255
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MULTICLIX LANCET DEVICE | LANCET DEVICE - FMK | ROCHE DIAGNOSTICS | FMK | * | 04466152160 | * | N | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-03-06 | 0 |