BURTON 0224100 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-02-05 for BURTON 0224100 * manufactured by Burton Medical Products Inc.

Event Text Entries

[288262] Examination was being performed on a pt. The free standing exam light was repositioned. The mechanical stop failed and the lamp swung around and struck the pt in the eye.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 443437
• MDR Report Key: 443437
• Date Received: 2003-02-05
• Date of Report: 2002-07-24
• Date of Event: 2002-05-22
• Report Date: 2002-07-24
• Date Reported to FDA: 2003-01-10
• Date Added to Maude: 2003-02-21
• 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 Sequence Number: 1

• Brand Name: BURTON
• Generic Name: EXAMINATION LIGHT
• Product Code: KYT
• Date Received: 2003-02-05
• Model Number: 0224100
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: 2 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 432412
• Manufacturer: BURTON MEDICAL PRODUCTS INC
• Manufacturer Address: 21100 LASSEN STREET CHATSWORTH CA 91311 US

Device Sequence Number: 2

• Brand Name: BURTON
• Generic Name: EXAMINATION
• Product Code: KYT
• Date Received: 2003-02-05
• Model Number: 0102110
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: 2 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 432414
• Manufacturer: BURTON MEDICAL PRODUCTS INC
• Manufacturer Address: 21100 LASSEN STREET CHATSWORTH CA 91311 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-02-05