FDA Adverse Event
Malfunction
Summary report: N
REGARD
MDR report key: 21843981
·
Received April 15, 2025
Report
- Report Number
- 3004513970-2025-00004
- Event Type
- Malfunction
- Date Received
- April 15, 2025
- Date of Event
- March 18, 2025
- Report Date
- April 15, 2025
- Manufacturer
- RESOURCE OPTIMIZATION & INNOVATION, LLC
- Product Code
- FYA
- PMA / PMN Number
- K093169
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
AFTER CONDUCTING A REVIEW OF MANUFACTURING RECORDS ASSOCIATED WITH THE LOT REPORTED, IT WAS CONCLUDED THAT THE GOWN LOT MET ALL SPECIFICATIONS AND ASTM SPECIFICATION F2407 STANDARDS. THE STRIKE THROUGH OCCURED ON A NON CRITICAL ZONE ON THE UPPER SLEEVE SEAM THAT IS NOT REINFORCED AS IS REQUIRED FOR THE CRITICAL ZONES TO MEET AAMI PB AAMI3 STANDARDS.
Description of Event or Problem · 0
THE CUSTOMER REPORTED STRIKE THROUGH WHILE USING THE GOWN. THE CUSTOMER STATED THAT THE STRIKETHROUGH OCCURRED ON THE LOWER AND UPPER ARM, ESPECIALLY AROUND THE UPPER ARM SEAMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 101326 | REGARD | REINFORCED SURGICAL GOWN, L | FYA | RESOURCE OPTIMIZATION & INNOVATION, LLC | AS3RGREINFSTL-REG | AX4007001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |