AMS 700 INFLATABLE PENILE PROSTHESIS 700

Adverse Event reported on 3/6/2012

Device Attributes
AttributeValue
ManufacturerAMERICAN MEDICAL SYSTEMS, INC.
Brand NameAMS 700 INFLATABLE PENILE PROSTHESIS
Device TypeIPP
Product CodeFAE
Model Number700
Catalog Number
Device Operator0LP
AMERICAN MEDICAL SYSTEMS, INC. AMS 700 INFLATABLE PENILE PROSTHESIS IPP Back to Search Results
Model Number 700
Event Date 08/10/2011
Event Type  Malfunction  
Event Description

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.

 
Manufacturer Narrative

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.

 
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Source: FDA