FDA Adverse Event
Malfunction
Summary report: N
CARDINAL HEALTH
MDR report key: 19201655
·
Received April 29, 2024
Report
- Report Number
- 19201655
- Event Type
- Malfunction
- Date Received
- April 29, 2024
- Date of Event
- March 21, 2024
- Report Date
- March 22, 2024
- Manufacturer
- CARDINAL HEALTH 200, LLC
- Product Code
- OGR
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- DE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ENT PACK FOUND TO HAVE SLICE MARK IN BACK TABLE COVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1305568 | CARDINAL HEALTH | EAR, NOSE, AND THROAT SURGICAL TRAY | OGR | CARDINAL HEALTH 200, LLC | SEN12BSMFL | 170566 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |