FDA Adverse Event
Injury
Summary report: N
EQUALINE MULTI-PURPOSE NO RUB STERILE SOLUTION
MDR report key: 4136216
·
Received October 2, 2014
Report
- Report Number
- 2026940-2014-00009
- Event Type
- Injury
- Date Received
- October 2, 2014
- Date of Event
- September 12, 2014
- Report Date
- November 4, 2014
- Manufacturer
- KC PHARMACEUTICALS, INC.
- Product Code
- LPN
- PMA / PMN Number
- K010559
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BASED ON THE INITIAL REPORT, THE DATE OF EVENT IS BEST ESTIMATED TO BE (B)(6) 2014. PENDING TESTING RESULTS.
Description of Event or Problem · 1
THIS IS A FOLLOW-UP REPORT. INITIAL REPORT WAS SENT ON 10/02/2014.
Description of Event or Problem · 1
ONE (1) PATIENT (B)(6) STATED THAT SHE EXPERIENCED A BURNING SENSATION IN THE EYES AFTER USING MEDICAL DEVICE, EQUALINE MULTI-PURPOSE NO RUB STERILE SOLUTION LOT NUMBER 125394 EXP. 02/2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 614887 | EQUALINE MULTI-PURPOSE NO RUB STERILE SOLUTION | LENS CARE SOLUTION | LPN | KC PHARMACEUTICALS, INC. | 125394 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |