N
Patient 1
THE YEAR IS THE ONLY KNOWN PART OF MANUFACTURE DATE. WE HAVE DEFAULTED TO THE FIRST OF THE YEAR.
MAUDE MDR 9891406
- MDR report key
- 9891406
- Report number
- 3011393376-2020-01177
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-19
- Date received
- 2020-03-27
- 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
- NA GREG SMITH
- Address
- 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US
- Phone
- 317-317-3175
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SOFTCLIX ? LANCET DEVICE | LANCET DEVICE | ROCHE DIABETES CARE, INC. | FMK | 07350422001 | GWX043 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-27 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.