Tactra?

Malleable Penile Prosthesis

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
 
Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, and potential adverse events.
 
The Tactra? Malleable Penile Prosthesis is intended for use in the treatment of erectile dysfunction (impotence) in adult males. Implanting a penile prosthesis will damage or destroy any remaining natural ability to have a spontaneous erection, as well as make other treatment options impossible.
 
Men with diabetes, spinal cord injuries, or skin infections may have an increased risk of infection. Implantation may result in penile shortening, curvature or scarring.
 
Potential adverse events may include device malfunction/failure leading to additional surgery, device/tissue erosion, infection, and pain/soreness. MH-611819-AA
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