FDA Adverse Event
Malfunction
Summary report: N
CARDINAL HEALTH
MDR report key: 8398791
·
Received March 7, 2019
Report
- Report Number
- 8398791
- Event Type
- Malfunction
- Date Received
- March 7, 2019
- Date of Event
- January 28, 2019
- Report Date
- January 28, 2019
- Manufacturer
- CARDINAL HEALTH 200, LLC
- Product Code
- IMD
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PATIENT'S FAMILY BROUGHT HOT PACK OUT OF ROOM AND STATED THAT IT BUSTED AND SQUIRTED ACROSS THE ROOM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194048 | CARDINAL HEALTH | PACK, HOT OR COLD, DISPOSABLE | IMD | CARDINAL HEALTH 200, LLC | 3014001565 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |