FDA investigates complaint of XXXX in spermicidal condom user.

@entity1 @entity566 @entity158 @entity25605
Currently, the US Food and Drug Administration (FDA) is investigating a complaint that the Ramses Extra spermicidal condom may have caused severe @entity158 in a user. The condom, which received marketing approval from FDA in 1982, contains the spermicidal lubricant @entity25605 -9, which reduces the number of active sperm and consequently decreases the risk of pregnancy. Lee Mathews of the FDA's office of compliance is investigating the complaint, filed in August 1983. The @entity1 experienced "excruciating @entity158 " on urination after using the spermicidal condom, according to FDA documents. The @entity1 indicated in the complaint that the @entity158 possibly resulted from the condom's spermicide entering her husband's urethra. The @entity158 subsided after several hours. She reported that her husband had never used the spermicidal condom before and had no known @entity566 or sensitivities. A spokeswoman for the manufacturer, Schmid Products, Company, reported after investigating the complaint that the company saw "no reason to believe that there was a batch problem or a problem with that particular condom." Company records revealed no other complaints with that batch. No other samples were available for testing from the @entity1 filing the complaint, but "the fact that the wife did not have a problem also indicates there wasn't anything particularly wrong with that condom." Company officials did not interview the @entity1 who used the condom in question, but they did reply to him in writing and have heard nothing more from the couple. The Schmid spokeswoman indicated that there have been isolated instances of sensitivity to this product. A key factor behind FDA approval of the spermicidal condom was a study completed for Schmid by Dr. Edwin Dale. Dale's study involved 30 @entity1 , 19-46, who used both regular condoms and condoms treated with @entity25605 -9. He concluded that decreased sperm motility with the treated condoms was caused by cell fragmentation due to cell membrane disruption.
