FDA Adverse Event
Injury
Summary report: N
GAS
MDR report key: 327772
·
Received April 16, 2001
Report
- Report Number
- MW1021652
- Event Type
- Injury
- Date Received
- April 16, 2001
- Date of Event
- April 11, 2000
- Report Date
- April 16, 2001
- Manufacturer
- ALCON
- Product Code
- LPO
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT HAD PARS PLANA VITRECTOMY W/GAS INJECTION (GREATER VISUALIZATION DURING SURGERY). CAME IN FOR VASCULAR SURGERY FIVE DAYS LATER AND DID NOT INFORM ANESTHESIA WHO USED NITRIC OXIDE AS INDUCTION AGENT. PT NOW BLIND. ALCON HAS PROVIDED BRACELETS TO BE PLACED ON THIS PT S/P GAS INJECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17239 | GAS | ISPAN PERFLOROPROPANE C3 F8 | LPO | ALCON | * | 063455 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Disability |