AMS 700? CXR TENACIO? PUMP
Received Jul 17, 2026 · Event occurred Jun 23, 2026
Report 2124215-2026-38448 · MDR key 25856053
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404463Catalog number
72404463
Lot number
1100546874
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
67 YR · Male
- Purulent Discharge
- Unspecified Infection
- Pain
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED SCROTAL PAIN. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE PHYSICIAN IDENTIFIED PURULENT MATERIAL (PUS) WITHIN THE SCROTUM, CONFIRMING THE PRESENCE OF AN INFECTION AT THE IMPLANT SITE. THE AFFECTED AREA WAS THOROUGHLY CLEANED AND THE IPP WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A TACTRA DEVICE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100823328. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4)