AMS 700 MS PUMP
Received Jul 8, 2026 · Event occurred Apr 15, 2026
Report 2124215-2026-36765 · MDR key 25757022
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404310Catalog number
72404310
Lot number
1000485870
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
42 YR · Male
- Unspecified Infection
- Swelling/ Edema
Narrative
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 72404161. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1000314810. MODEL/CATALOG DESCRIPTION: RESERVOIR 65ML PC. 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. INFECTION IS ACKNOWLEDGED WITHIN THE INSTRUCTIONS FOR USE (IFU) AND IS NOT RELATED TO OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. THE REPORTED PATIENT SYMPTOM OF INFECTION IS A KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED A PENILE AND SCROTAL INFECTION. A REVISION PROCEDURE WAS PERFORMED DURING WHICH THE PHYSICIAN EXPLANTED AND REPLACED THE DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS.