4201. Misbranding of La Parfaite syringe.   U. S. v. 161 Devices, etc    (F. D. C.
No. 33280.   Sample No. 1159-L.)
LIBEL FILED :    On or about June 12, 1952, Southern District of Florida.
ALLEGED SHIPMENT :   On or about November 16, 1950, from Paris, France.
PRODUCT: 161 La Parfaite syringes in individual boxes at Highland City, Fla.,
together with a number of circulars entitled "Feminine Hygiene is made 100-
Effective."
The device consisted of a porcelain fitting equipped with a rubber inlet tube
tand a rubber outlet tube.   The rubber inlet tube had a number of openings
near the tip and one opening at the very tip end.   In operation, a supply of
fluid under hydrostatic pressure would be forced into the vagina through the
rubber inlet tube.
RESULTS OF INVESTIGATION : Upon receipt of the devices from France, the con-
signee, Mrs. Grace Kern, doing business as the Florida Hygienic Co., at High-
land City, Fla., repackaged the devices into individual boxes, together with
1 copy of the above-mentioned circular which had been printed for the
consignee.
NATURE OF CHARGE: Misbranding, Section 502 (a), certain statements in the
above-mentioned circular were false and misleading. The statements repre-
sented and suggested that use of the device was effective for insuring a sound,
healthy body for women, enabling the penetration of a cleansing solution to
all parts of the vaginal tract, preventing cancer which might be caused by
bruising the uterus through use of other types of douching devices, and pro-
viding a safe method of douching. The device was not effective for the
intended purposes, and it was not capable of fulfilling the promises of benefit
made for it.
Further misbranding, Section 502 (j), the article was dangerous to health
when used in the dosage and with the frequency and duration prescribed,
recommended, and suggested in its labeling since the jet of fluid emerging
from the hole in the tip of the device would enter the uterus and cause
injury.
The device was misbranded in the above respects while held for sale after
shipment in interstate commerce.
DISPOSITION : November 16,1953. Grace Kern, claimant, having filed an answer
to the libel and later having withdrawn such answer, judgment of condemna-
tion was entered and the court ordered that the devices and the labeling be
destroyed.
VIOLATIVE SALES OF PRESCRIPTION DRUGS