AMS 700 LGX? TENACIO? PUMP

Additional Manufacturer Narrative

UDI FIELD (D4) CONCOMITANT PRODUCT UDI FOR RESERVOIR IS (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS PRESENTED WITH FLUID IN THE SCROTUM. AS PER REVISION SURGERY PHYSICIAN ATTRIBUTED THAT THE HEMATOMA WITHIN THE CORPORAL BODIES AND THE FLUID IN THE SCROTUM TO THE PATIENT MEDICATION. THE DEVICE WAS EXPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

Additional Manufacturer Narrative

UDI FIELD (D4) CONCOMITANT PRODUCT UDI FOR RESERVOIR IS (B)(4). CORRECTION TO FIELD H7: IF REMEDIAL ACT INIT, TYPE. CORRECTION TO FIELD H9: CORRECTION/REMOVAL REPORTING NUMBER. CORRECTION TO FIELD A2: AGE AT TIME OF EVENT. CORRECTION TO FIELD A2: UNIT OF MEASURE AGE. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. SWELLING, EDEMA AND HEMATOMA ARE ACKNOWLEDGED WITHIN THE DFU AND ARE NOT RELATED TO OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. THE REPORTED PATIENT SYMPTOMS OF SWELLING, EDEMA AND HEMATOMA ARE KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH FLUID IN THE SCROTUM. AS PER REVISION SURGERY PHYSICIAN ATTRIBUTED THAT THE HEMATOMA WITHIN THE CORPORAL BODIES AND THE FLUID IN THE SCROTUM TO THE PATIENT MEDICATION. THE DEVICE WAS EXPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.