FDA Adverse Event
Malfunction
Summary report: N
ISPAN PERFLUOROPROPANE (C3F8) GAS
MDR report key: 1476273
·
Received July 2, 2009
Report
- Report Number
- 2518435-2009-00005
- Event Type
- Malfunction
- Date Received
- July 2, 2009
- Date of Event
- May 20, 2009
- Report Date
- June 26, 2009
- Manufacturer
- AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
- Product Code
- LPO
- PMA / PMN Number
- P900066
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THERE HAVE BEEN NO OTHER REPORTS INVOLVING THIS LOT NUMBER. (B) (4).
Description of Event or Problem · 1
A FACILITY REPORTED THE PRODUCT DID NOT LAST AS LONG AS ANTICIPATED WHEN IT WAS USED ON A PATIENT DURING VITREOUS-RETINAL SURGERY. AN ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED APPROXIMATELY TWO AND A HALF WEEKS LATER TO REPLACE THE PRODUCT. THE SURGEON REPORTED THE PATIENT IS EXPECTED TO RECOVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISPAN PERFLUOROPROPANE (C3F8) GAS | PRODUCT CODE LPO/INTRAOCULAR GAS | LPO | AIR LIQUIDE HEALTHCARE AMERICA CORPORATION | C3F8, 125 G | 722715 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |