N
Patient 0
MEDICAL QUESTIONNAIRE RECEIVED ON MAY 06, 2026.
MAUDE MDR 25247724
- MDR report key
- 25247724
- Report number
- 8021764-2026-00007
- Event key
- 0
- Event type
- 3
- Date of event
- 2026-04-20
- Date received
- 2026-05-21
- Adverse event
- 1
- 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 194581 | CARDINAL HEALTH UNISTIK 3 NORMAL | LANCET | OWEN MUMFORD LIMITED | FMK | AT 6201 | 12661 | N | N | ||||
| 241006 | CARDINAL HEALTH UNISTIK 3 NORMAL | LANCET | OWEN MUMFORD LIMITED | FMK | AT 6201 | 12661 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2026-05-21 | 0 | O |
Event Narratives#
D
Patient 0
CARDINAL HEALTH REPORTED TO US THAT ONE OF THEIR CUSTOMERS REPORTED THAT THE NEEDLE DID NOT RETRACT AND WAS STUCK WHEN PICKING DEVICE UP AFTER USING. MEDICAL QUESTIONNAIRE RECEIVED MAY 06, 2026.