FDA Adverse Event
Other
Summary report: N
ESCALON
MDR report key: 183204
·
Received August 17, 1998
Report
- Report Number
- 2183477-1998-00002
- Event Type
- Other
- Date Received
- August 17, 1998
- Report Date
- August 14, 1998
- Manufacturer
- ESCALON MEDICAL
- Product Code
- BXX
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE REPORTED CASES INVOLVED VITRECTOMY, FOLLOWED BY FLUID/AIR EXCHANGE AND THEN C3F8 ADMINISTRATION. STANDARD 24-HOUR POST-SURGICAL EVALUATION DETECTED ELEVATED INTRAOCULAR PRESSURE, WHICH SUBSEQUENTLY HAD TO BE RELIEVED. PROBLEMS WERE FOUND IN FOUR OUT OF APPROX 30 CASES PERFORMED OVER THE PAST SEVERAL MONTHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESCALON | UNIVERSAL GAS KIT | BXX | ESCALON MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention | ESCALON TR9085 REGULATOR.| ESCALON TR9089 C3F8 GAS (MFG BY SCOTT MEDICAL). |