VENTILATION TUBE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-09-27 for VENTILATION TUBE * manufactured by Smith & Nephew Richards, Inc..

Event Text Entries

[26491] Ventilation tube surgically placed in ear 2/15/90, extruded 9/5/91, leaving a hole in tympanic membrane; large hole which never healed over a given period of time, under medical supervision. Pt now has maximum conductive hearing loss and must always protect from water contamination. Bones of hearing also misaligned due to hole.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1009906
• MDR Report Key: 37257
• Date Received: 1996-09-11
• Date of Report: 1996-07-22
• Date of Event: 1991-09-05
• Date Added to Maude: 1996-09-13
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VENTILATION TUBE
• Generic Name: VENTILATION TUBE 12 MM
• Product Code: LBL
• Date Received: 1996-09-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 38619
• Manufacturer: SMITH & NEPHEW RICHARDS, INC.
• Manufacturer Address: 1450 E BROOKS RD MEMPHIS TN 38116 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention; 3. Deathisabilit	1996-09-11