TACTRA MALLEABLE PENILE PROTHESIS

Additional Manufacturer Narrative

DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THIS TACTRA DEVICE HAD EXTRUDED. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.