FDA Adverse Event
Malfunction
Summary report: N
VERSAGOWN (ASSURE WEAR)
MDR report key: 8581863
·
Received May 6, 2019
Report
- Report Number
- 8581863
- Event Type
- Malfunction
- Date Received
- May 6, 2019
- Date of Event
- April 26, 2019
- Report Date
- April 29, 2019
- Manufacturer
- AMD MEDICOM INC. (AMD RITMED)
- Product Code
- OEA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A NEW SEALED BAG OF YELLOW ISOLATION GOWNS HAS A HAIR INSIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 375543 | VERSAGOWN (ASSURE WEAR) | NON-SURGICAL ISOLATION GOWN | OEA | AMD MEDICOM INC. (AMD RITMED) | A69962 | 78905 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |