FDA Adverse Event
Other
Summary report: N
VISINE FOR CONTACTS
MDR report key: 757640
·
Received September 1, 2006
Report
- Report Number
- 2246407-2006-00007
- Event Type
- Other
- Date Received
- September 1, 2006
- Date of Event
- August 27, 2006
- Report Date
- September 1, 2006
- Manufacturer
- PFIZER INC.
- Product Code
- LPN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT HAS NOT BEEN RETURNED FOR FAILURE ANALYSIS/ LABORATORY TESTING. USER ERROR MAY HAVE CONTRIBUTED TO THE EVENT.
Description of Event or Problem · 1
THIS IS THE SECOND OF TWO REPORTS RECEIVED BY PFIZER IN 2006, FROM THE SAME REPORTER. AER 2246407-2006-00006 IS A SERIOUS REPORT. AN ANONYMOUS CONSUMER REPORTED A FEMALE DRANK HALF A BOTTLE OF VISINE FOR CONTACTS (GLYCERIN, HYDROXYPROPYLMETHYLCELLULOSE) ONCE IN 2007, "BECAUSE SHE SAW IT IN A MOVIE AND WANTED TO SEE WHAT WOULD HAPPEN." AFTER INGESTING THE PRODUCT, SHE HAD STOMACH CRAMPS AND WAS TIRED. THAT SAME DAY, THE EVENTS RESOLVED. THE REPORTER WAS LOST TO FOLLOW-UP DUE TO NO AVAILABLE CONTACT INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VISINE FOR CONTACTS | CONTACT LENS PRODUCT | LPN | PFIZER INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Other |