InjuryJCW
AMS 700 CX MS PUMP
Received Jun 12, 2026 · Event occurred Jun 3, 2026
Report 2124215-2026-31582 · MDR key 25488727
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404233-12Catalog number
72404233-12
Lot number
1100772880
Product problems
- Mechanical Problem
- Material Puncture/Hole
Patient
71 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. UPON EXPLANT THE PHYSICIAN IDENTIFIED THE TUBING TO THE RESERVOIR WAS BROKEN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100776442. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).