MAUDE Adverse Event Report: LUMITEX MD LIGHTMAP; SURGICAL ILLUMINATOR

Catalog Number REF SA3550

Device Problem Melted (1385)

Patient Problem Burn(s) (1757)

Event Date 07/25/2016

Event Type  malfunction  

Event Description

Upon undraping the patient, we discovered that the patient had a burn at the area where the light mat and deaver had been placed upon her.When we looked at the light mat that had been used, we saw that the plastic at the area where the light mat connects to the cord was melted.

• Brand Name: LIGHTMAP
• Type of Device: SURGICAL ILLUMINATOR
• Manufacturer (Section D): LUMITEX MD
• MDR Report Key: 5875129
• MDR Text Key: 52210394
• Report Number: MW5064051
• Device Sequence Number: 1
• Product Code: FDG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: REF SA3550
• Device Lot Number: 103337
• Other Device ID Number: PN#005539
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1