FDA Adverse Event
Malfunction
Summary report: N
SRI LIQUID PROOF SURGICAL GOWN
MDR report key: 525784
·
Received February 18, 2004
Report
- Report Number
- 1527607-2004-00001
- Event Type
- Malfunction
- Date Received
- February 18, 2004
- Date of Event
- January 6, 2004
- Report Date
- February 5, 2004
- Manufacturer
- SRI/SURGICAL EXPRESS, INC.
- Product Code
- FYB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DOCTOR REPORTED EXPERIENCING STRIKE THROUGH OF FLUIDS INSIDE SLEEVE (CUFF AREA) OF A LIQUID PROOF SURGICAL GOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SRI LIQUID PROOF SURGICAL GOWN | LARGE SURGICAL GOWN | FYB | SRI/SURGICAL EXPRESS, INC. | NA | NOT REPORTED TO SRI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |