FDA Adverse Event
Malfunction
Summary report: N
REGARD
MDR report key: 20304803
·
Received September 25, 2024
Report
- Report Number
- 3004513970-2024-00001
- Event Type
- Malfunction
- Date Received
- September 25, 2024
- Date of Event
- September 4, 2024
- Report Date
- September 25, 2024
- Manufacturer
- RESOURCE OPTIMIZATION & INNOVATION, LLC
- Product Code
- FYA
- UDI-DI
- 00326053117756
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE OEM FOR THE AAMI LEVEL 3 GOWN REPORTED IN THIS EVENT WAS ENGAGED TO INVESTIGATE ANY POTENTIAL ROOT CAUSES OF THE REPORTED EVENT RELATED TO THE MANUFACTURING OF THE GOWN. THE CAPA IS ATTACHED TO THIS RECORD.
Description of Event or Problem · 0
GOWN WAS DONNED BY SCRUB TECH DURING SURGICAL CASE. THE INDIVIDUAL NOTICED THAT HER SCRUBS FELT DAMP AGAINST HER SKIN WHERE THE OUTSIDE OF THE GOWN HAD BLOOD CASTOFF FROM PROCEDURE. UPON REMOVAL OF THE GOWN, SCRUB TECH DISCOVERED THAT HER SCRUBS HAD BLOOD SOAKED ONTO THEM FROM THE OUTSIDE OF THE GOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1198165 | REGARD | AAMI LEVEL 3 SURGICAL GOWN, REINFORCED SMS, STERILE X LARGE | FYA | RESOURCE OPTIMIZATION & INNOVATION, LLC | A3ISRGSTXL-REG | 20K206H | 00326053117756 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |