MAUDE Adverse Event Report: INTEGRA BURLINGTON, MA, INC. LED HEADLIGHT W/ BATTERIES &AC/DC POWER SUPPLY -US; LIGHTING

Catalog Number 90520US

Device Problems Electrical /Electronic Property Problem (1198); Device Emits Odor (1425)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Customer initially reports electric burn smell and cannot turn led off; (b)(6) 2015 customer reports event occurred during routine biomedical inspection, no harm done.

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported info.

• Brand Name: LED HEADLIGHT W/ BATTERIES &AC/DC POWER SUPPLY -US
• Type of Device: LIGHTING
• Manufacturer (Section D): INTEGRA BURLINGTON, MA, INC.; burlington MA 01803
• Manufacturer Contact: sandra lee ; 315 enterprise dr; 6099366828
• MDR Report Key: 4594723
• MDR Text Key: 5463548
• Report Number: 1222895-2015-00006
• Device Sequence Number: 1
• Product Code: FSR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 90520US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1