FDA Adverse Event
Malfunction
Summary report: N
CARDINAL HEALTH
MDR report key: 21967285
·
Received May 6, 2025
Report
- Report Number
- 21967285
- Event Type
- Malfunction
- Date Received
- May 6, 2025
- Date of Event
- February 10, 2025
- Report Date
- May 1, 2025
- Manufacturer
- CARDINAL HEALTH 200, LLC
- Product Code
- OJH
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
4 LAPS NOT 5 IN FOOT PACK, SOPOCFASRC, EXP 2026-09-01, LOT 416068, REP NOTIFIED. MANUFACTURER RESPONSE FOR LAPAROTOMY PADS, (BRAND NOT PROVIDED) (PER SITE REPORTER).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2102516 | CARDINAL HEALTH | ORTHOPEDIC TRAY | OJH | CARDINAL HEALTH 200, LLC | SOPOCFASRC | 416068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |