MAUDE Adverse Event Report: INTEGRA BURLINGTON, MA, INC. ANCILLARY, HEADBAND UL PLUS BI

Catalog Number AX1375BIF

Device Problem Melted (1385)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Event Description

Customer initially reports a person using integra headlight suffered a burn to the head from the module melting when using our mlx light source.(b)(4) 2014, regional business manager for integra reported that the hospital risk manager informed him that there was no burn to anyone, no harm done.(b)(4) 2014 dealer confirms this is a melting module.(b)(4) 2014, although risk manager promised answers to email, none received yet.Number 2 of 3 devices reported.

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 information.

• Brand Name: ANCILLARY, HEADBAND UL PLUS BI
• Type of Device: NA
• Manufacturer (Section D): INTEGRA BURLINGTON, MA, INC.; burlington MA 01803
• Manufacturer Contact: sandra lee ; 315 enterprise drive; 6099366828
• MDR Report Key: 4077355
• MDR Text Key: 4825025
• Report Number: 1222895-2014-00021
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AX1375BIF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2014
• Initial Date FDA Received: 08/22/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1