AMS 700 CX MS PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100883188. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) NOTICED THAT THE GLANS PENIS WAS POSITIONED AT APPROXIMATELY A 90-DEGREE ANGLE. THE PATIENT INITIALLY THOUGHT THAT THE CATHETER WAS PULLING ON THE DISTAL END OF THE PENIS. HOWEVER, AFTER THE CATHETER WAS REMOVED, THE GLANS REMAINED IN THE SAME POSITION. THE PATIENT ALSO NOTED THAT THE CYLINDERS DID NOT EXTEND TO THE TIP OF THE PENIS. AT A FOLLOW-UP APPOINTMENT, THE PHYSICIAN AGREED THAT THE APPEARANCE WAS ABNORMAL. AN APPOINTMENT WAS SCHEDULED FOR MAGNETIC RESONANCE IMAGING (MRI) TO FURTHER EVALUATE THE CONDITION AND DETERMINE APPROPRIATE MANAGEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.