FDA Adverse Event
Injury
Summary report: N
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
MDR report key: 1062064
·
Received June 10, 2008
Report
- Report Number
- 1313525-2008-00020
- Event Type
- Injury
- Date Received
- June 10, 2008
- Report Date
- May 15, 2008
- Manufacturer
- BAUSCH & LOMB, INC.
- Product Code
- LPN
- PMA / PMN Number
- KO11796
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT AVAILABLE FOR EVAL AND LOT NUMBER INFO IS UNK. BASED ON AVAILABLE INFO, NO ROOT CAUSE CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
PER PLAINTIFF'S ORIGINAL COMPLAINT, PLAINTIFF CLAIMS THE PRODUCT WAS DEFECTIVE AND INFECTED HER EYE WITH FUSARIUM FUNGUS. PLAINTIFF WAS ALLEGEDLY HOSPITALIZED AND SCHEDULED TO HAVE ADD'L SURGERY IN 2008 TO POSSIBLY REMOVE HER EYE. NO FURTHER DETAILS ARE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RENU MULTIPLUS MULTI-PURPOSE SOLUTION | 86LPN | LPN | BAUSCH & LOMB, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |