FDA Adverse Event
Summary report: N
*
MDR report key: 3820074
·
Received April 24, 2014
Report
- Report Number
- 3820074
- Date Received
- April 24, 2014
- Date of Event
- February 6, 2014
- Report Date
- April 24, 2014
- Manufacturer
- COVIDIEN
- Product Code
- GDY
- Report Source
- User Facility report
- Reporter Location
- AL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ONLY 8 RAY-TEC SPONGES WERE IN THE CUSTOM PACK. THERE SHOULD HAVE BEEN 10. PACKAGES OF SPONGES THAT DO NOT HAVE THE CORRECT NUMBER CREATE THE RISK OF INCORRECT COUNT OR A RETAINED SURGICAL ITEM. THE PACK WAS REMOVED FROM THE FIELD AND FROM THE ROOM. SPONGES AND PACK INFORMATION FORWARD TO MATERIALS MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249544 | * | SURGICAL SPONGES | GDY | COVIDIEN | LSRHHMAJBAA | 684131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |