AMS 700 CXR
Received Jul 17, 2026 · Event occurred Jun 16, 2026
Report 2124215-2026-38462 · MDR key 25856096
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404013Catalog number
72404013
Lot number
1100785019
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
67 YR · Male
- Inflammation
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED AN INFLAMMATORY REACTION. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 72404310. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100894610. MODEL/CATALOG DESCRIPTION: PUMP MS. UNIQUE IDENTIFIER (UDI) #: (B)(4). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF ADVERSE EVENT RELATED TO PATIENT CONDITION WAS ASSIGNED TO THIS INVESTIGATION.