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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA BURLINGTON, MA, INC LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - US; LIGHTING
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INTEGRA BURLINGTON, MA, INC LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - US; LIGHTING Back to Search Results
Catalog Number 90520US
Device Problems Device Emits Odor (1425); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/27/2015
Event Type  malfunction  
Event Description
Customer initially reports that he had an led unit that was no longer working.The unit's back switch where you can adjust intensity does not allow the light to be turned off.Also, the operating room reported a funny small coming from the unit when turned on.A smoky smell like something was burning (b)(6) 2015 no harm done, no further information available.
 
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.
 
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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 drive
6099366828
MDR Report Key4535955
MDR Text Key5505242
Report Number1222895-2015-00005
Device Sequence Number1
Product Code FSR
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K110528
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/27/2015
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 Number90520US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/27/2015
Initial Date FDA Received02/19/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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