Cylinder and pump: lot/serial #: (b)(4). Catalogue#: 718314004. Date of mfg: 06/2011. Conceal reservoir: lot/serial #: (b)(4). Catalogue#: 720185-01. Date of mfg: 7/2011.
On (b)(6) 2011, the pt was originally implanted with an inflatable penile prosthesis (ipp) device. On (b)(6) 2011, ams received information from the pt the device was not functioning. No additional information has been provided if the pt's device has been revised.