FDA Adverse Event
Malfunction
Summary report: N
HUMIRA PEN STRT CD/UC/HS.
MDR report key: 13771740
·
Received March 14, 2022
Report
- Report Number
- MW5108166
- Event Type
- Malfunction
- Date Received
- March 14, 2022
- Report Date
- March 10, 2022
- Manufacturer
- UNKN
- Product Code
- NSC
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE PATIENT STATES THAT SHE WAS GIVING HERSELF THE FIRST LOADING DOSE OF THE HUMIRA FROM THE HUMIRA PEN STARTER KIT FOR CD/UC/HS WHICH COMES WITH #380MG/0.8ML PENS. SHE STATES SHE WAS GIVING HERSELF THE INJECTION FROM THE FIRST OF 2 PENS FOR HER LOADING DOSE AND THAT WHILE HOLDING THE PEN TO HER SKIN, NEVER HEARD ANY CLICK OR FELT ANYTHING AFTER WAITING FOR AT LEAST 15 SECONDS SO PULLED THE PEN AWAY TO SEE IF THERE WAS SOMETHING WRONG WITH THE PEN AND WHEN PULLING THE PEN AWAY, THE PEN RELEASED THE DOSE A LIQUID CAME OUT EVERYWHERE. NO MISSED DOSE: NO ADVERSE EVENTS REPORTED; UNKNOWN IF DEVICE AVAILABLE FOR RETURN; MEDICAL DOCTOR AWARE. NO FURTHER INFORMATION PROVIDED. ABBVIE. REPORTED TO (B)(6) BY : PATIENT/CAREGIVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 41454 | HUMIRA PEN STRT CD/UC/HS. | INJECTOR, PEN. | NSC | UNKN | 1154587 | ||
| 41455 | HUMIRA PEN STRT CD/UC/HS. | INJECTOR, PEN. | NSC | UNKN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |