FDA Adverse Event
Other
Summary report: N
6280 STERILE USP NORMAL SALINE 0.9% SODIUM CHLORIDE
MDR report key: 18399613
·
Received December 26, 2023
Report
- Report Number
- MW5149583
- Event Type
- Other
- Date Received
- December 26, 2023
- Date of Event
- August 27, 2023
- Report Date
- December 21, 2023
- Manufacturer
- NURSE ASSIST, LLC
- Product Code
- NGT
- Report Source
- Voluntary report
- Reporter Location
- CT, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
PRODUCT WAS SOLD AS STERILE SALINE AND IT WASN'T. I PUT MY TRUST IN THE PRODUCT AND IT COULD HAVE LEAD TO INFECTION. USED 1 WEEK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2266327 | 6280 STERILE USP NORMAL SALINE 0.9% SODIUM CHLORIDE | SALINE, VASCULAR ACCESS FLUSH | NGT | NURSE ASSIST, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Female |