UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-01-12 for UNK * manufactured by Unk.

Event Text Entries

[588369] Patient stated, he was using an "indwelling" which he had to remove and clean often. One time while removing or inserting, the patient inhaled the prosthesis. Pt went to hosp. And found device transparent to xray. Next day pt went to different hosp and ent used scope and retrieved the prosthesis from where it had lodged, where the trachea branches into the 2 lungs.
Patient Sequence No: 1, Text Type: D, B5

[7938022] It is unclear if this device is our device as we have no sales history or rx on file for this patient. The indwelling vp wesell is a clinician placed and removed device. Instructions clearly state this.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2025182-2006-00008
• MDR Report Key: 805837
• Report Source: 04
• Date Received: 2007-01-12
• Date of Report: 2006-12-14
• Date Mfgr Received: 2006-12-11
• Date Added to Maude: 2007-01-19
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Street: 1110 MARK AVE
• Manufacturer City: CARPINTERIA CA 93013
• Manufacturer Country: US
• Manufacturer Postal: 93013
• Manufacturer Phone: 8056843304
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: UNK
• Generic Name: VOICE PROSTHESIS
• Product Code: MCK
• Date Received: 2007-01-12
• Model Number: *
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 793338
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2007-01-12