FDA Adverse Event
Malfunction
Summary report: N
REGARD
MDR report key: 21664452
·
Received March 21, 2025
Report
- Report Number
- 3004513970-2025-00002
- Event Type
- Malfunction
- Date Received
- March 21, 2025
- Date of Event
- March 11, 2025
- Report Date
- March 21, 2025
- Manufacturer
- RESOURCE OPTIMIZATION & INNOVATION, LLC
- Product Code
- FYC
- PMA / PMN Number
- K212504
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE LOT NUMBER AND DATE OF MANUFACTURE ARE NOT INCLUDED IN THIS REPORT DUE TO THE INFORMATION RELATED TO THE SPECIFIC LOT NUMBER NOT BEING PROVIDED BY THE FACILITY WHO REPORTED THE COMPLAINT.
Description of Event or Problem · 0
OUR TEAM HAS EXPERIENCED ISSUES WITH THE ADHESIVE NOT STICKING WELL AND THE GOWN FALLING DOWN THEIR SHOULDERS MID PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 900099 | REGARD | GOWN ISOLATION AAMI 3 BLUE CUFF, XL | FYC | RESOURCE OPTIMIZATION & INNOVATION, LLC | A3ISOGXLNS-REG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |