MalfunctionFHW
DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC
Received Jun 10, 2026
Report MW5189264 · MDR key 25469499
Device
Generic name
Device, Impotence, Mechanical/hydraulic
Manufacturer
Coloplast Manufacturing Us, LlcModel number
IPPPatient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WITH A NON-(B)(6) DEVICE UNDERWENT A SURGERY DUE TO UNSPECIFIED REASONS. NO ADDITIONAL INFORMATION REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).