ASTROGLIDE NATURAL PERSONAL LUBRICANT

Additional Manufacturer Narrative

A MESSAGE WAS SENT TO CDRH-(B)(4)-MDR POLICY RESPONSE LINE ON (B)(4) 2015 WHEN IT WAS REALIZED THAT THIS EMDR WOULD NOT BE COMPLETE WITHIN THE 30 DAYS DUE TO THE TIME IT WAS TAKING TO SET UP THE ESG ACCOUNT. MR. (B)(4), THE EXEMPTIONS COORDINATOR INSTRUCTED US TO COMPLETE THE SET UP PROCESS AND THEN SUBMIT THE EMDR RATHER THAN SEND IT THROUGH WITH AN EXEMPTION FOR PAPER REPORTING. THIS IS THE FIRST TIME WE HAD A COMPLAINT THAT SEEMED TO BE A REPORTABLE EVENT.

Description of Event or Problem

THE PATIENT CLAIMS THAT UPON INITIAL APPLICATION OF ASTROGLIDE NATURAL PERSONAL LUBRICANT SHE EXPERIENCED SEVERE BURNING. HER VAGINAL AREA BEGAN TO SWELL AND SHE SAID SHE RAN A 103 DEGREES TEMPERATURE. SHE WENT TO THE EMERGENCY ROOM OF HER LOCAL HOSPITAL WHERE THEY GAVE HER AN IV DRIP OF BENADRYL. SHE WAS TOLD SHE HAD A SEVERE REACTION AND TO CONTINUE TO TAKE BENADRYL AND USE ICE PACKS FOR THE VAGINAL SWELLING. SHE STATED THE SYMPTOMS WERE STILL PRESENT WHEN SHE CALLED TO REPORT THE INCIDENT ON (B)(6) 2015. SHE WAS ADVISED TO SEE HER DOCTOR AGAIN IF THE SYMPTOMS ARE STILL PRESENT. SHE SHARED THAT SHE IS DIABETIC AND HAS A GENETIC LIVER DISEASE AND IS WAITING FOR A LIVER TRANSPLANT. SHE ALSO STATED THAT SHE IS EXTREMELY CHEMICAL SENSITIVE. ON (B)(6), BIOFILM CUSTOMER SERVICE CALLED THE PATIENT TO ASK A FEW MORE QUESTIONS. THE PATIENT STATED HER ALLERGIC REACTION STARTED ON (B)(6) 2015 ALTHOUGH INITIALLY SHE STATED IT HAPPENED ON (B)(6). THE PATIENT STATED THAT HER SYMPTOMS HAD GREATLY IMPROVED BUT THAT SHE STILL HAS SOME BURNING. SHE STATED THAT SHE HAS HAD THIS TYPE OF ALLERGIC REACTION IN THE PAST BUT NOT AS SEVERE AND THAT SHE WAS ALLERGIC TO LATEX, RUBBING ALCOHOL AND PARABENS. SHE STATED SHE WAS NOT USING ANY OTHER PRODUCTS, MEDICATIONS, OR DEVICES CONCURRENTLY WHEN SHE HAD THE REACTION. SHE STATED HER DOCTOR TOLD HER THAT IT WAS DEFINITELY THE BOTANICAL INGREDIENTS IN THE ASTROGLIDE NATURAL PRODUCT THAT SHE REACTED TO. SHE SAID IT SHOWED UP IN HER PAP SMEAR. BIOFILM CUSTOMER SERVICE ASKED IF SHE COULD PROVIDE ANY MEDICAL DOCUMENTATION, LAB RESULTS, OR A DOCTORS STATEMENT DESCRIBING THE SEVERITY OF THE INCIDENT. SHE WAS GOING TO SEE THE DOCTOR LATER THAT DAY SO SHE SAID SHE WOULD ASK HIM FOR A STATEMENT. SHE MENTIONED THAT HE MAY NOT BECAUSE OF (B)(6). THE PATIENT CALLED BACK TO BIOFILM CUSTOMER SERVICE LATER THAT DAY AND SAID SHE SHOULD BE COMPLETELY FINE WITHIN A COUPLE OF DAYS BUT THAT THE DOCTOR DID NOT CREATE ANY TYPE OF STATEMENT FOR HER TO PROVIDE TO US.