SOUND TEC IMPLANT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-03 for SOUND TEC IMPLANT * manufactured by Sound Tec Inc..

Event Text Entries

[344175] Implant of soundtec prosthesis was done 2002. The pt required surgery 2004 to have the prosthesis removed due to it malfunctioning.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 563247
• MDR Report Key: 563247
• Date Received: 2005-01-03
• Date of Report: 2004-12-20
• Date of Event: 2004-11-17
• Date Facility Aware: 2004-11-22
• Report Date: 2004-12-20
• Date Reported to Mfgr: 2004-12-20
• Date Added to Maude: 2005-01-06
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SOUND TEC IMPLANT
• Generic Name: EAR PROSTHESIS
• Product Code: FZD
• Date Received: 2005-01-03
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: PART# 300-0039-001
• Operator: NOT APPLICABLE
• Device Availability: *
• Device Age: 2 YR
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 552975
• Manufacturer: SOUND TEC INC.
• Manufacturer Address: 2601 NORTHWEST EXPRESSWAY ST. OKLAHOMA CITY OK * US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2005-01-03