UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-02-22 for UNK * manufactured by Unk.

Event Text Entries

[15030627] The pt, with dementia, complained of pain on swallowing of one month's duration. Pt denied foreign body ingestion. Ap and lateral chest films showed dentures lodged in the pt's upper esophagus. The dentures could not be removed endoscopically. Therefore, surgical exploration and an esophagotomy were required to remove the dentures. The dentures in this pt were detectable by chest films because they were radiopaque. Reporter proposes to ban radiolucent dentures, which would have been undetectable.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1018280
• MDR Report Key: 266363
• Date Received: 2000-02-22
• Date of Report: 2000-02-21
• Date of Event: 1998-03-01
• Date Added to Maude: 2000-03-03
• 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
• 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: UNK
• Generic Name: RADIOLUCENT DENTURES
• Product Code: EKO
• Date Received: 2000-02-22
• Model Number: UNK
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 257859
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2000-02-22