AMS 700 CX MS PUMP
Received Jun 11, 2026 · Event occurred May 17, 2026
Report 2124215-2026-31448 · MDR key 25480353
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404233-12Catalog number
72404233-12
Lot number
1100914894
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
74 YR · Male
- Bacterial Infection
- Unspecified Infection
- Discomfort
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THIS PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED TENDERNESS TO THE SCROTAL SITE. UPON EXAMINATION THE PHYSICIAN IDENTIFIED AN INFECTION AT THAT SCROTAL SITE. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED WITH A TACTRA DEVICE. THERE WERE NO DEVICE ISSUES, AND THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100903314. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).