N
Patient 1
THE DEVICE USED WAS NOT RETURNED, SO A PREVIOUS INVESTIGATION FOR THE SAME REPORTED FAULT, NON-RETRACTING NEEDLE WAS USED TO CLOSE THE COMPLAINT, (B)(4).
MAUDE MDR 8287419
- MDR report key
- 8287419
- Report number
- 8021764-2019-00003
- Event key
- 0
- Event type
- 3
- Date received
- 2019-01-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- 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 | AT 1022 | 032914 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-01-29 | 0 | 1. O |
Event Narratives#
D
Patient 1
DURING GLYCEMIC CONTROL OF A PATIENT, AFTER USING THE DEVICE IN THE USUAL CONDITIONS, WHEN THE NURSE REMOVED HER GLOVES, SHE FOUND SHE WAS BLEEDING FROM A FINGERTIP ON HER LEFT HAND. IN LOOKING MORE DEEPLY, THE DEVICE SEEMED THAT IT DID NOT RETRACT ENTIRELY.