D
Patient 0
CARDINAL HEALTH REPORTED TO US THAT ONE OF THEIR CUSTOMERS COMPLAINED THAT THE NEEDLE IS NOT DISCHARGING/ RETRACTING.
MAUDE MDR 25035838
- MDR report key
- 25035838
- Report number
- 8021764-2026-00004
- Event key
- 0
- Event type
- 3
- Date received
- 2026-04-29
- Adverse event
- 0
- Product problem
- 1
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 0
- Initial report to FDA
- 1
- Event location
- 0
Manufacturer Contact#
- Contact
- MRS. PATTY HANEY
- Address
- 1755 WEST OAK COMMONS CT. MARIETTA GA 30062 US
- Phone
- 770-770-7709
- Report source
- M
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 418574 | CARDINAL HEALTH UNISTIK 3 NORMAL | LANCET | OWEN MUMFORD LIMITED | FMK | AT 6201 | 12648 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2026-04-29 | 0 | O |