MalfunctionFAF
*
Received Oct 1, 2004 · Event occurred Sep 24, 2004
Report 547144 · MDR key 547144
Device
Generic name
Testicular Prosthesis
Manufacturer
MentorModel number
96-450-1329Catalog number
*
Lot number
SS44760-017
Product problems
- Explanted
- Inflation Problem
- Replace
- Use of Device Problem
Patient
17 YR
- Surgical procedure
Narrative
Description of Event or Problem
IN 2004 EXCHANGE OF PROSTHESIS FOR COMPARABLE SIZE. DURING FOLLOW-UP VISIT PROSTHESIS WAS NOTED TO NOT BE FULLY INFLATED. TWENTY-ONE DAYS LATER PROSTHESIS REPLACED. MD STATES THAT THERE WAS INADEQUATE PLACEMENT OF SALINE INTO THE PROSTHESIS. THE PROSTHESIS WAS EXCHANGED AND ADEQUATE FLUID INSTILLED.