ASTROGLIDE ULTRA GENTLE GEL PERSONAL LUBRICANT
Received Jul 31, 2019 · Event occurred Jul 27, 2019
Report MW5088567 · MDR key 8847061
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
29 YR
- Burning Sensation
- Burn, Thermal
- Burning Sensation
- Burn, Thermal
Narrative
Description of Event or Problem
I HAVE RECENTLY BOUGHT ASTROGLIDE ULTRA GENTLE GEL PERSONAL LUBRICANT AT (B)(6) IN (B)(6) EARLIER THAT WEEK. I HAVE USED THE ASTROGLIDE BRAND IN THE PAST AND HAVE BEEN SATISFIED WITH THE PRODUCT. UPON EXTERNAL VAGINAL APPLICATION OF THIS ONE, I FELT A BURNING SENSATION THAT JOLTED ME AND BROUGHT ME TO TEARS. I TRIED WIPING IT OFF BUT SOON RAN TO SHOWER TO RINSE IT OFF. AFTER THE SHOWER, I DID A QUICK (B)(6) SEARCH OF THE PRODUCT AND NOTED SIMILAR REVIEWS ON THE ASTROGLIDE WEBSITE. ALL OF THE NEGATIVE REVIEWS SEEMED TO REPORT THE SAME PAINFUL BURNING. I ASSUME IT WAS A BAD BATCH AS IT IS ONLY THE MOST RECENT REVIEWS, FROM THE PAST MONTH OR SO, ARE NEGATIVE AND THE REST ARE FINE. THE NEXT MORNING AFTER VAGINAL SEX WITH MY PARTNER, HE NOTED THAT HE ALSO HAD A SLIGHT BURNING SENSATION ON THE BASE OF HIS PENIS. I ALSO HAD A SLIGHT BURNING SENSATION WITHIN MY VAGINAL CANAL. I GUESS THE PRODUCT WAS SO ABSORBANT THAT IT REMAINED ON THE SKIN OVERNIGHT, EVEN AFTER WASHING. PLEASE INVESTIGATE AND REMOVE THIS PRODUCT FROM STORE SHELVES AS SOON AS POSSIBLE. FDA SAFETY REPORT ID# (B)(4).