inforMED
MalfunctionFHW

DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC

Received Jun 10, 2026

Report MW5189263 · MDR key 25469482

Device

Generic name

Device, Impotence, Mechanical/hydraulic

Model number

IPP

Patient

NA · Unknown

  • Insufficient Information

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR UNKNOWN REASON INVOLVING A PREVIOUS NON-(B)(6) DEVICE. A NEW INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).