FDA Adverse Event
Injury
Summary report: N
QUALITY CHOICE MULTI-PURPOSE SOLUTION
MDR report key: 3610650
·
Received February 6, 2014
Report
- Report Number
- 2026940-2014-00002
- Event Type
- Injury
- Date Received
- February 6, 2014
- Date of Event
- December 16, 2013
- Report Date
- March 25, 2014
- Manufacturer
- KC PHARMACEUTICALS, INC.
- Product Code
- LPN
- PMA / PMN Number
- K010559
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS A FOLLOW UP REPORT. INITIAL REPORT SENT ON 02/06/14.
Additional Manufacturer Narrative · 1
DATE OF EVENT: DATE PROVIDED IS CLOSEST ESTIMATED DATE OF EVENT.
Description of Event or Problem · 1
ONE(1) PATIENT (B)(6) STATED THAT SHE EXPERIENCED AN ALLERGIC REACTION IN HER EYES AFTER USING MEDICAL DEVICE, QUALITY CHOICE MULTI-PURPOSE SOLUTION. THE PATIENT MEDICAL RECORD IS NOT AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
THIS IS A FOLLOW UP REPORT. INITIAL REPORT WAS SENT ON 02/06/2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78288 | QUALITY CHOICE MULTI-PURPOSE SOLUTION | LENS CARE SOLUTION | LPN | KC PHARMACEUTICALS, INC. | C12916 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |