FDA Adverse Event
Injury
Summary report: N
SAGE ORAL CARE SUCTION SWAB
MDR report key: 4774323
·
Received May 12, 2015
Report
- Report Number
- MW5042700
- Event Type
- Injury
- Date Received
- May 12, 2015
- 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. DATES OF USE: SINCE (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311172 | SAGE ORAL CARE SUCTION SWAB | SUCTION SWAB | KXF | SAGE PRODUCTS INC | 42625 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |