FDA Adverse Event
Malfunction
Summary report: N
MAXXIM MEDICAL
MDR report key: 195733
·
Received November 6, 1998
Report
- Report Number
- 1035160-1998-00007
- Event Type
- Malfunction
- Date Received
- November 6, 1998
- Report Date
- November 5, 1998
- Manufacturer
- MAXXIM MEDICAL
- Product Code
- LRO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE HIGH PRESSURE MONITORING LINE IS ALLEGED TO HAVE ERUPTED DURING A SURGICAL PROCEDURE, SPRAYING DYE AND BLOOD ON THREE OR STAFF MEMBERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXXIM MEDICAL | CUSTOM PROCEDURE PACK | LRO | MAXXIM MEDICAL | 6071195 | 7043096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |