FDA Adverse Event
Malfunction
Summary report: N
CARDINAL HEALTH
MDR report key: 19446894
·
Received June 3, 2024
Report
- Report Number
- 19446894
- Event Type
- Malfunction
- Date Received
- June 3, 2024
- Date of Event
- April 24, 2024
- Report Date
- May 2, 2024
- Manufacturer
- CARDINAL HEALTH 200, LLC
- Product Code
- OEA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
STOCKING ISOLATION GOWNS FROM A BRAND NEW PACKAGE AND NOTED SOILED SPOTS ON TWO OF THEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1885291 | CARDINAL HEALTH | NON-SURGICAL ISOLATION GOWN | OEA | CARDINAL HEALTH 200, LLC | BXT2100PG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |