Import Alert 78-01
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 78-01
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination Of Penis Enlargers And Erection Maintaining Rings"
Reason for Alert:
The use of penis enlargers and erection maintaining rings may have harmful effects. They may aggravate existing medical conditions such a Pegronies disease, priapism, and urethral stricture. They may contuse or cause rupture of the subcutaneous blood vessels, which may produce hemorrhage and hematoma formation. Additionally, frequent use of erection maintaining rings may result in ecchymosis of the proximal portion of the penis and scrotum, and the lymphatic stasis of the penis. Prolonged use of the rings may cause gangrene of the penis.
Basically, the labeling of these devices falsely states or implies they will treat impotence, prolong erection, and increase the dimensions of the penis.
These devices generally fall into the following categories:
1. Mechanical stretching devices.
Those employing weights, or lines tied to other parts of the body (such as the knee), to affect tension on the penis.
2. Vacuum operated devices.
Those employing a sealing principle in the area of the base of the penis and an evacuation mechanism to drop the atmospheric pressure around the penis thereby effecting increased blood flow.
3. Constrictive Rings.
Those devices which constrict the base of the penis after erection has been achieved and cause the erection to be maintained by blocking the normal circulation of blood from the penis.
4. Supportive devices.
Those devices which function as a splint or cradle in order to maintain a resemblance of turgidity
Basically, the labeling of these devices falsely states or implies they will treat impotence, prolong erection, and increase the dimensions of the penis.
These devices generally fall into the following categories:
1. Mechanical stretching devices.
Those employing weights, or lines tied to other parts of the body (such as the knee), to affect tension on the penis.
2. Vacuum operated devices.
Those employing a sealing principle in the area of the base of the penis and an evacuation mechanism to drop the atmospheric pressure around the penis thereby effecting increased blood flow.
3. Constrictive Rings.
Those devices which constrict the base of the penis after erection has been achieved and cause the erection to be maintained by blocking the normal circulation of blood from the penis.
4. Supportive devices.
Those devices which function as a splint or cradle in order to maintain a resemblance of turgidity
Guidance:
Districts may detain without physical examination, unless exempted by 21 CFR, Section 801.109, all devices in the above described categories.
Districts may also be able to detain such devices under IA 89-08, "DWPE of devices w/o approved PMA's or IDE's and other devices not equivalent or no 510K."
If there is any question whether or not any device encountered falls into the above described categories, contact CDRH, Division of Compliance Operations, HFZ-332.
Districts may also be able to detain such devices under IA 89-08, "DWPE of devices w/o approved PMA's or IDE's and other devices not equivalent or no 510K."
If there is any question whether or not any device encountered falls into the above described categories, contact CDRH, Division of Compliance Operations, HFZ-332.
Product Description:
Penis Enlargers
Erection Maintaining Devices
Erection Maintaining Devices
Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device, the label of which fails to bear adequate directions for use [Misbranding, Section 502(f)(1)]."
OASIS charge code - DIRECTIONS
OASIS charge code - DIRECTIONS
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