FDA Adverse Event
Injury
Summary report: N
SAGE ORAL CARE SUCTION SWAB
MDR report key: 3792992
·
Received April 30, 2014
Report
- Report Number
- MW5035905
- Event Type
- Injury
- Date Received
- April 30, 2014
- Date of Event
- April 16, 2014
- Report Date
- April 21, 2014
- Manufacturer
- SAGE PRODUCTS, INC.
- Product Code
- KXF
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE GREEN PORTION OF THE SUCTION SWAB HAD TO BE EXTRACTED DURING AN EGD PROCEDURE AS IT WAS OBSTRUCTING THE NASOGASTRIC TUBE PLACEMENT. THE FOREIGN BODY WAS BROKEN OFF FROM THE STICK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 260115 | SAGE ORAL CARE SUCTION SWAB | SUCTION SWAB | KXF | SAGE PRODUCTS, INC. | 42625 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |