InjuryJCW
AMS 700? CX TENACIO? PUMP
Received Jul 15, 2026 · Event occurred Jun 19, 2026
Report 2124215-2026-38119 · MDR key 25830654
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404434Catalog number
72404434
Lot number
1100863861
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
49 YR · Male
- Capsular Contracture
- Hematoma
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) WAS HAVING TROUBLE LOCATING AND USING THE PUMP DUE TO CAPSULE AND HEMATOMA. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE PUMP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100625261. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).