InjuryJCW
AMS 700 LGX? TENACIO? PUMP
Received Jul 10, 2026 · Event occurred May 1, 2026
Report 2124215-2026-37178 · MDR key 25786451
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404453Catalog number
72404453
Lot number
1100715523
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
61 YR · Unknown
- Erosion
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED PUMP EROSION THROUGH SCROTAL INCISION. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED WITH MALLEABLE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100817591. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).