CONCEAL
Received Jul 2, 2026 · Event occurred Jun 4, 2026
Report 2124215-2026-35473 · MDR key 25690789
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72018201Catalog number
72018201
Lot number
1000068601
Product problems
- Mechanical Problem
- Material Puncture/Hole
Patient
65 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 72404273. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1000127557. MODEL/CATALOG DESCRIPTION: CX 18CM SNAP FIT RT. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: 72404310. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1000178294. MODEL/CATALOG DESCRIPTION: PUMP MS. UNIQUE IDENTIFIER (UDI) #: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED TO THE HOSPITAL WITH A NON-FUNCTIONAL DEVICE. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED AND UPON INSPECTION, THERE WAS A HOLE FOUND IN THE RESERVOIR. AS A RESULT, THE PHYSICIAN REMOVED AND REPLACED THE RESERVOIR AND PUMP. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE, AND THERE WAS NO ADDITIONAL INFORMATION PROVIDED.