LOTTEL ELEVATOR NH 660 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-01-18 for LOTTEL ELEVATOR NH 660 * manufactured by Bausch/laum Surgical Stores.

Event Text Entries

[138194] Pt underwent turbinectomy, piece of instrument broke off. Could not be found in the nasal cavity, x-ray revealed it in the stomach. It was removed via gastroscopy.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 312861
• MDR Report Key: 312861
• Date Received: 2001-01-18
• Date of Report: 2001-01-08
• Date of Event: 2000-12-02
• Date Facility Aware: 2000-12-07
• Report Date: 2001-01-08
• Date Reported to FDA: 2001-01-03
• Date Reported to Mfgr: 2001-01-03
• Date Added to Maude: 2001-01-23
• 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: 0
• 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: LOTTEL ELEVATOR
• Generic Name: EAR NOSE & THROAT PRODUCTS
• Product Code: KAD
• Date Received: 2001-01-18
• Model Number: NH 660
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 302613
• Manufacturer: BAUSCH/LAUM SURGICAL STORES
• Manufacturer Address: 3365 TREE CT INDUSTRIAL BLVD ST LOUIS MO 631226694 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2001-01-18