MalfunctionFAE
PENILE PROSTHESIS
Received Jun 10, 2026
Report MW5189268 · MDR key 25469541
Device
Generic name
Prosthesis, Penile
Manufacturer
Coloplast Manufacturing Us, LlcPatient
NA · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY INVOLVING A NON-(B)(6) TITAN INFLATABLE PENILE PROSTHESIS DEVICE FOR UNSPECIFIED REASONS. A NEW INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).