FDA Adverse Event
Malfunction
Summary report: N
REGARD
MDR report key: 18294064
·
Received December 8, 2023
Report
- Report Number
- 3004513970-2023-00002
- Event Type
- Malfunction
- Date Received
- December 8, 2023
- Date of Event
- November 14, 2023
- Report Date
- December 8, 2023
- Manufacturer
- RESOURCE OPTIMIZATION & INNOVATION, LLC
- Product Code
- FYA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
GOWNS HAD STRIKE THROUGH LEAVING FLUIDS ON THE USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 703167 | REGARD | NON-REINFORCED GOWN, AAMI LEVEL 3 | FYA | RESOURCE OPTIMIZATION & INNOVATION, LLC | A3SRGSTXL-REG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |