FDA Adverse Event
Other
Summary report: N
BARRIER ULTRA PROTECTION SURGICAL GOWN, EXTRA LARGE
MDR report key: 225160
·
Received May 27, 1999
Report
- Report Number
- 1618732-1999-00147
- Event Type
- Other
- Date Received
- May 27, 1999
- Report Date
- April 28, 1999
- Manufacturer
- JOHNSON & JOHNSON MEDICAL
- Product Code
- FYA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE SALES REP REPORTED: OPERATING ROOM PERSONNEL SUSTAINED STRIKETHROUGH OF FLUIDS AROUND THE ARM AND CHEST AREA. IT WAS REPORTED THAT THE STRIKETHROUGH OCCURRED AT THE BEGINNING OF THE OPEN HEART PROCEDURE AND WENT DOWN TO THE SCRUBS. THERE WAS NO REPORT OF BLOODBORNE PATHOGENS INVOLVED AND NO REPORTED ADVERSE PT OR USER OUTCOME. THE ACTUAL SAMPLE IS NOT AVAILABLE BUT A SAMPLE FROM THE SAME LOT WAS RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARRIER ULTRA PROTECTION SURGICAL GOWN, EXTRA LARGE | GOWN, SURGICAL | FYA | JOHNSON & JOHNSON MEDICAL | NA | 190199F03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |