AMS 700 CX MS PUMP
Received Jul 10, 2026 · Event occurred Jun 16, 2026
Report 2124215-2026-37108 · MDR key 25783118
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404233-12Catalog number
72404233-12
Lot number
1000465034
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
61 YR · Male
- Erosion
- Unspecified Infection
- Urinary Retention
Narrative
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 1000456794, MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML, UNIQUE IDENTIFIER (UDI) #: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THIS INFLATABLE PENILE PROSTHESIS (IPP) DUE TO EROSION AND INFECTION. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE DEVICE HAD ERODED DISTALLY THROUGH THE URETHRA AND CONFIRMED AN INFECTION. THE DEVICE WAS EXPLANTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.