InjuryJCW
AMS 700? CX TENACIO? PUMP
Received Jul 20, 2026 · Event occurred Jun 24, 2026
Report 2124215-2026-38827 · MDR key 25876942
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404438Catalog number
72404438
Lot number
1100821373
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
71 YR · Male
- Discomfort
- Unspecified Tissue Injury
Narrative
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100881835. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD ATTENUATED TUNICA AND WAS UNCOMFORTABLE. AS A RESULT, THE CYLINDER WAS EXPLANTED, DOWNSIZED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.