[147803]
User reported experiencing an adverse reaction after using product, a sexual lubricant. User explained that they applied some of the product using their fingertips. They immediately experienced a burning sensation as well as itching, pain and inflammation. They said the pain was so bad that no sexual intercourse took place. Their genitals are still swollen today but the itching has subsided some. They reported that they had not used any other product prior to using the product in question. They do not have a history of sensitive skin. Couple told field officer that they have used this product in the past with no problem. However, this bottle was labeled "new improved" and they noted a strong vanilla-like odor. Pt's spouse said the contents of the bottles they have used prior to the one in question were always colorless and odorless. They did note that one of the ingredients listed in the ingredient statement on the bottle in question is "flavor". Per phonecon on 11/8/99 with mayer labs, inc. The product is made at libby laboratories, berkeley, ca. No other complaints on this lot number have been received. Mfr reported that the only differences between the "new improved" product and the former product is that a low concentration of vanilla has been added to the new variety, and there has been a slight change in the viscosity. On 12/27/99, rptr left a phone message with the complainant, asking them to contact rptr. The user's spouse left a voice mail message on the evening of 12/28/99. User's spouse stated that they thought that the investigation was complete. Added that they also have been in contact with the "national office". User's spouse stated that the mfr of the product contacted them, and that they mailed the remaining consumer portion of the product to them at their request. They stated that they thought that the pharmacy where the product was purchased, had pulled the product from their shelves, and that the pharmacist may have retained some of the product. The pharmacist on duty stated that they had no knowledge of the complaint. Pharmacist said that it appeared that none of the product remained on the shelves. On 1/3/2000, field officer visited the place of purchase and noted that 3 bottles of new improved aqua lube were on the shelves. However, the lot number 4563, was different from that of the complainant's 4057. A 2nd pharmacist stated that they had not gathered the info that field office had requested. Both pharmacists reiterated that they had no recollection of the complaint. Field officer asked who would usually respond to over-the-counter product complaints and they replied that it would be either themself or an assistant. Field officer reviewed the establishment's "return to mfr" log from the date of the complaint to date and this product was not listed. No sample was collected.
Patient Sequence No: 1, Text Type: D, B5