ISPAN PERFLUOROPROPANE (C3F8) GAS
Report
- Report Number
- 0002518435-2025-00012
- Event Type
- Injury
- Date Received
- February 20, 2025
- Date of Event
- November 23, 2024
- Report Date
- January 28, 2024
- Manufacturer
- AIRGAS THERAPEUTICS LLC
- Product Code
- LPO
- PMA / PMN Number
- P900066
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
NO SAMPLE WAS RETURNED FOR EVALUATION. AN ANALYSIS OF THE RETAIN SAMPLE FROM THE SAME LOT OF PERFLUOROPROPANE SHOWED THAT THE PRODUCT WAS PFP AND MET ALL RELEASE CRITERIA. NOTHING WAS FOUND THAT WOULD ACCOUNT FOR THE REPORTED EVENT.
NO SAMPLE WAS RETURNED FOR EVALUATION. AN ANALYSIS OF THE RETAIN SAMPLE FROM THE SAME LOT OF PERFLUOROPROPANE SHOWED THAT THE PRODUCT WAS PFP AND MET ALL RELEASE CRITERIA. NOTHING WAS FOUND THAT WOULD ACCOUNT FOR THE REPORTED EVENT. THIS IS A DUPLICATE OF MDR# 0002518435-2025-00007.
A HEALTHCARE PROFESSIONAL VIA STUDY REPORTED THAT AFTER VITRECTOMY SURGERY, THE PATIENT EXPERIENCED MILD SECONDARY GLAUCOMA IN THE LEFT EYE. THE PATIENT WAS GIVEN DRUG TREATMENT AND THE EVENT WAS RESOLVED.
A HEALTHCARE PROFESSIONAL VIA STUDY REPORTED THAT AFTER VITRECTOMY SURGERY, THE PATIENT EXPERIENCED MILD SECONDARY GLAUCOMA IN THE LEFT EYE. THE PATIENT WAS GIVEN DRUG TREATMENT AND THE EVENT WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 394696 | ISPAN PERFLUOROPROPANE (C3F8) GAS | INTRAOCULAR GAS | LPO | AIRGAS THERAPEUTICS LLC | 300502 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| R |