AMS 700? CX TENACIO? PUMP
Received Jun 30, 2026 · Event occurred Jun 1, 2026
Report 2124215-2026-34994 · MDR key 25673584
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404434Catalog number
72404434
Lot number
1100806868
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
73 YR · Male
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100904998. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4). 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. INFECTION IS ACKNOWLEDGED WITHIN THE INSTRUCTIONS FOR USE (IFU) AND IS NOT RELATED TO OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. THE REPORTED PATIENT SYMPTOM OF INFECTION IS A 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 A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE DEVICE WAS EXPLANTED. A FULL WASHOUT WAS COMPLETED DURING THE PROCEDURE, AND A NEW DEVICE WAS IMPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.