LINVATEC 5071-002 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-05-07 for LINVATEC 5071-002 * manufactured by Linvatec.

Event Text Entries

[21393352] Battery pack connected to oscillator saw began smoking. Removed from or room to hallway-smoking increased. Sprayed with abc extinguisher.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 331190
• MDR Report Key: 331190
• Date Received: 2001-05-07
• Date of Report: 2001-05-03
• Date of Event: 2001-04-30
• Date Facility Aware: 2001-04-30
• Report Date: 2001-05-03
• Date Reported to FDA: 2001-05-03
• Date Reported to Mfgr: 2001-05-03
• Date Added to Maude: 2001-05-10
• 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
• 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: LINVATEC
• Generic Name: OSCILLATING SAW
• Product Code: HSO
• Date Received: 2001-05-07
• Returned To Mfg: 2001-04-30
• Model Number: 5071-002
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 320546
• Manufacturer: LINVATEC
• Manufacturer Address: 11311 CONCEPT BLVD LARGO FL 346434908 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2001-05-07