SCARAWAY SILICONE SCAR GEL
Received Aug 31, 2023 · Event occurred Jun 20, 2023
Report 3019867040-2023-00002 · MDR key 17663719
Device
Generic name
Scaraway Gel
Manufacturer
Alliance Pharma Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Blurred Vision
- Visual Impairment
- Blurred Vision
- Visual Impairment
Narrative
Description of Event or Problem
CONSUMER CONTACTED CUSTOMER SERVICE ON (B)(6) 2023 ASKING ABOUT COURSE OF ACTION AFTER SCARAWAY GEL ACCIDENTALLY GOT INTO HER EYE. CONSUMER APPLIED SCARAWAY GEL BENEATH HER EYEBROW, AND OVERNIGHT SOME OF THE GEL GOT INTO HER EYE. CONSUMER RINSED THE PRODUCT BUT STATES HER VISION WAS SLIGHTLY BLURRY/IMPAIRED. CONSUMER WAS DIRECTED TO SEEK MEDICAL ADVICE FROM A HEALTH CARE PROFESSIONAL. MULTIPLE FOLLOW UP ATTEMPTS WERE MADE, AND PER RESPONSE EMAIL FROM CONSUMER ON 7/19/23, THE CONSUMER ADVISED THAT SHE DID SEE A HEALTH CARE PROVIDER AND WAS GIVEN EYE DROPS, WHICH RELIEVED HER SYMPTOMS. NO FURTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
THE SUBMISSION WAS DELAYED DUE TO DIFFUCULTIES WITH IT SET UP. ALLIANCE PHARMA HAS COMMUNICATED WITH THE FDA ABOUT THIS ISSUE ((B)(6) 2023 ) AND WAS ADVISED TO MAKE A NOTE ON THE DELAY IN SECTION H OF THIS FORM.