FDA Adverse Event
Injury
Summary report: N
NURSE ASSIST, LLC
MDR report key: 19333447
·
Received May 16, 2024
Report
- Report Number
- 3002695476-2024-00025
- Event Type
- Injury
- Date Received
- May 16, 2024
- Date of Event
- August 31, 2023
- Report Date
- May 8, 2024
- Manufacturer
- NURSE ASSIST, LLC
- Product Code
- FRO
- UDI-DI
- 00850421008822
- PMA / PMN Number
- K083042
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
COMPLAINT (B)(4) FROM MEDWATCH MW5154072. REACHED OUT TO PATIENT ON 5/8/24 FOR ADDITIONAL INFORMATION.
Description of Event or Problem · 0
FROM MEDWATCH REPORT (MW5154072): USED NURSE ASSIST STERICARE PART # 6270 250ML STERILE SALINE SOLUTION ON OPEN LEG WOUND BEFORE I WAS NOTIFIED BY AMAZON OF THE RECALL. WOUND HEALING REQUIRED MORE MEDICAL ASSISTANCE THAN INITIALLY PROJECTED. USED THE SALINE TO WASH ON OPEN LEG WOUND 2X/DAY AS DOCTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 925238 | NURSE ASSIST, LLC | 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW BOTTLE TOP, | FRO | NURSE ASSIST, LLC | 6270 | 23055604 | 00850421008822 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |