AMS 700 CX MS PUMP
Received Jul 20, 2026 · Event occurred Jun 24, 2026
Report 2124215-2026-38927 · MDR key 25883611
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404231Catalog number
72404231
Lot number
0174964005
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
76 YR · Male
- Deformity/ Disfigurement
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH CURVATURE, RESULTING IN PATIENT DISSATISFACTION. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE IPP WAS REMOVED AND REPLACED WITH A TACTRA DEVICE. IT WAS NOTED THAT NO DEVICE RELATED ISSUES WERE PRESENT, THE DEVICE CYCLED PROPERLY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 0179070018. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).