AMS 700 CX MS PUMP
Received Jul 17, 2026 · Event occurred Apr 22, 2026
Report 2124215-2026-38495 · MDR key 25857810
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404234-14Catalog number
72404234-14
Lot number
1100442143
Product problems
- Inadequacy of Device Shape and/or Size
Patient
74 YR · Male
- Pain
- Discomfort
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED DISCOMFORT AND PAIN ASSOCIATED WITH THE LEFT CYLINDER. A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH IT WAS DETERMINED THAT THE LEFT CYLINDER WAS OVERSIZED. AS A RESULT, THE IPP WAS EXPLANTED AND REPLACED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100543471. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).