N
Patient 1
NO DEVICE WAS RETURNED, MODEL AND LOT NUMBER NOT IDENTIFIED, HOWEVER SIMILAR REPORTED INCIDENTS HAVE BEEN INVESTIGATED WITH (B)(4).
MAUDE MDR 8287420
- MDR report key
- 8287420
- Report number
- 8021764-2019-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-10-29
- Date received
- 2019-01-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. PATRICIA CRONAN
- Address
- 1755 WEST OAK COMMONS CT. MARIETTA GA 30062 US
- Phone
- 770-770-7709
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | UNISTIK 3 | LANCET | OWEN MUMFORD LIMITED | FMK | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-01-29 | 0 | 1. O |
Event Narratives#
D
Patient 1
A (B)(6) FIREFIGHTER USED A DEVICE ON A PATIENT AND ONCE FINISHED TRANSFERRED THE USED DEVICE INTO HIS HAND. THE NEEDLE DID NOT RETRACT AFTER USE AND THE FIREFIGHTER WAS INJURED. THE DEVICE WAS DISPOSED OF AND CURRENTLY THERE IS NO INFORMATION ON THE FIREFIGHTER.