inforMED
InjuryFZD

SOUND TEC IMPLANT

Received Jan 3, 2005 · Event occurred Nov 17, 2004

Report 563247 · MDR key 563247

Device

Generic name

Ear Prosthesis

Manufacturer

Sound Tec Inc.

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Explanted
  • Malfunction

Patient

70 YR

  • Surgical procedure
  • Hospitalization required

Narrative

Description of Event or Problem

IMPLANT OF SOUNDTEC PROSTHESIS WAS DONE 2002. THE PT REQUIRED SURGERY 2004 TO HAVE THE PROSTHESIS REMOVED DUE TO IT MALFUNCTIONING.