PROVOX NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-08-20 for PROVOX NI manufactured by Atos Medical.

Event Text Entries

[257350] Pt who recently passed away and rptr had understood that a member of the atos medical marketing team, representing the provox line of voice prostheses, attended laryngectomy meetings in pt's area. According to pt and the spouse, the atos rep claimed that the provox indwelling voice prosthesis (which is used by laryngectomized individuals following a surgical tracheoesophageal puncture for purposes of voice restoration) lasted longer and/or was more resistant to the colonization of candida albicans than the blom-singer indwelling voice prosthesis, mfg by inhealth technologies. A study has established this to not be true. Rptr has nearly 20 years experienced in caring for this throat cancer population of pts, and they have served for six years on the state board for speech pathology, upholding ethical practices for the profession in their state. Rptr has serious concerns about their pts being given inaccurate info which may constitute false claims. It has also come to rptr's attention that a marketing rep from atos medical shipped a prosthesis, which is a prescription item, to their pt without their knowledge and without a prescription and this is completely unacceptable because of the potential danger this poses for pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1025910
• MDR Report Key: 424804
• Date Received: 2002-08-20
• Date Added to Maude: 2002-10-31
• 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: OTHER HEALTH CARE PROFESSIONAL
• 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: PROVOX
• Generic Name: VOICE PROSTHESIS
• Product Code: MCK
• Date Received: 2002-08-20
• Model Number: NI
• Catalog Number: NI
• Lot Number: NI
• ID Number: NI
• Operator: LAY USER/PATIENT
• Device Availability: N
• Implant Flag: N
• Date Removed: I
• Device Sequence No: 1
• Device Event Key: 413858
• Manufacturer: ATOS MEDICAL
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-08-20