FDA Adverse Event
Malfunction
Summary report: N
REGARD
MDR report key: 21987535
·
Received May 8, 2025
Report
- Report Number
- 3004513970-2025-00005
- Event Type
- Malfunction
- Date Received
- May 8, 2025
- Date of Event
- April 18, 2025
- Report Date
- May 8, 2025
- Manufacturer
- RESOURCE OPTIMIZATION & INNOVATION, LLC
- Product Code
- OEA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
OUR FIRM WAS PROVIDED ADDITIONAL INFORMATION RELATED TO THE STRIKE THROUGH EVENTS THAT DESCRIBES WHAT THE USER FACILITY IDENTIFIED AFTER DISCUSSING THE REPORTED EVENTS WITH THEIR STAFF. "I ORDERED 1 CASE OF THE REGARD AAMI LEVEL 2 ISOLATION GOWN REF# (B)(4). STAFF WERE TREATING THESE AS THOUGH LEVEL 4 GOWNS AND WERE SURPRISED WHEN I EXPLAINED THAT GOWNS COME IN DIFFERENT LEVELS OF PROTECTION AS A LEVEL 2 GOWN WILL NOT PROTECT AGAINST SATURATION."
Description of Event or Problem · 0
THE END USER FACILITY REPORTED STRIKE-THROUGH. "I SPILLED A LITTLE IV FLUID ON THE SLEEVE AND IT BLED RIGHT THROUGH. I WAS HELPING WITH A LACERATION AND SOME OF THE BLOOD GOT ON THE SLEEVE AND IT WAS ALL OVER MY ARM BY THE TIME WE GOT DONE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 848207 | REGARD | GOWN ISOL PULLOVER AAMI2 UNIV | OEA | RESOURCE OPTIMIZATION & INNOVATION, LLC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |