inforMED

TOROSA

Received Aug 21, 2013

Report 3352294 · MDR key 3352294

Device

Generic name

Prosthesis, Testicular

Model number

*

Catalog number

450-1329

Lot number

3660017

Product problems

  • Leak/Splash
  • Packaging Problem

Patient

*

  • No Patient Involvement

Narrative

Description of Event or Problem

THE NIGHT PRIOR TO THE SURGERY THE PHYSICIAN REVIEWED THE YOU-TUBE VIDEO TO REFRESH HIS KNOWLEDGE ON USE AND FILLING OF THE PROSTHETIC IMPLANT. ON THE DAY OF SURGERY THE FIRST IMPLANT WAS FILLED AND WAS FOUND TO HAVE A LEAK. THE SECOND PROSTHESIS WAS FILLED AND WAS ALSO FOUND TO HAVE A LEAK. AS ONLY TWO IMPLANTS WERE AVAILABLE WITHIN THE LOCAL AREA, THE PATIENT WAS CLOSED WITHOUT THE IMPLANT. UPON REVIEW OF THE CASE IT WAS FOUND THAT WHILE THE YOU-TUBE VIDEO OPENS WITH A SCREEN DISCUSSING USE OF A NEEDLE STOP, THE VIDEO ITSELF DOES NOT SHOW THE NEEDLE STOP IN USE DURING ANY PART OF THE VIDEO. IT WAS ALSO DISCOVERED THAT THE NEEDLE STOPS ARE NOT IDENTIFIED INSIDE THE PACKAGING. THE MANUAL THAT COMES WITH THE PACKAGE MAKES A REFERENCE TO THE NEEDLE STOP ON PAGE 7 BUT DOES NOT HAVE ANY DETAILS ON WHAT IT LOOKS LIKE.