FDA Adverse Event
Malfunction
Summary report: N
CARDINAL HEALTH
MDR report key: 14873708
·
Received June 30, 2022
Report
- Report Number
- 14873708
- Event Type
- Malfunction
- Date Received
- June 30, 2022
- Date of Event
- April 30, 2022
- Report Date
- May 11, 2022
- Manufacturer
- CARDINAL HEALTH 200, LLC
- Product Code
- FDE
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- DE
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
OR REPORTS THAT A CARDINAL HEALTH CUSTOM LAP CHOLE PACK CONTAINED X6 TAGS WHEN IT SHOULD HAVE ONLY HAD X5.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 944494 | CARDINAL HEALTH | LAPAROSCOPY KIT | FDE | CARDINAL HEALTH 200, LLC | PG40LCKGM01 | 804793 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |