FDA Adverse Event
Death
Summary report: N
0.9% SODIUM CHLORIDE IRRIGATION USP
MDR report key: 18191678
·
Received November 21, 2023
Report
- Report Number
- MW5148357
- Event Type
- Death
- Date Received
- November 21, 2023
- Report Date
- November 20, 2023
- Manufacturer
- NURSE ASSIST, LLC.
- Product Code
- NGT
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
- Health Professional
- *
Narratives
Description of Event or Problem · 0
CDER RECEIVED THE MEDWATCH REPORT. THE REPORTER STATES THE IMPACTED INDIVIDUAL HAD AN ULCER WOUND THAT GOT INFECTED WITH CANDIDA AURIS. THEY WASHED THE WOUND DAILY WITH WATER. THERE WERE WHITE SPORES (FUNGAL GROWTH) AROUND THE WOUNDS. THE HOSPITAL DETERMINED THAT CANDIDA AURIS GOT INTO THE BLOOD STREAM OF THE IMPACTED INDIVIDUAL AND THE INDIVIDUAL WENT INTO SEPTIC SHOCK AND DIED. THE REPORTER STATED THAT THEY HAVE THE MEDICAL RECORDS FOR THE DECEASED INDIVIDUAL. INFECTION LEADING TO DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 712989 | 0.9% SODIUM CHLORIDE IRRIGATION USP | SALINE, VASCULAR ACCESS FLUSH | NGT | NURSE ASSIST, LLC. | 22083817 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death |