ANCILLARY, HEADBAND UL PLUS BI AX1375BIF

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2014-08-22 for ANCILLARY, HEADBAND UL PLUS BI AX1375BIF manufactured by Integra Burlington, Ma, Inc..

Event Text Entries

[18540008] 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 3 of 3 devices reported.
Patient Sequence No: 1, Text Type: D, B5


[18863630] 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1222895-2014-00022
MDR Report Key4077354
Report Source06,08
Date Received2014-08-22
Date of Report2014-07-29
Date Mfgr Received2014-08-13
Date Added to Maude2014-09-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactSANDRA LEE
Manufacturer Street315 ENTERPRISE DRIVE
Manufacturer Phone6099366828
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameANCILLARY, HEADBAND UL PLUS BI
Generic NameNA
Product CodeFSR
Date Received2014-08-22
Catalog NumberAX1375BIF
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA BURLINGTON, MA, INC.
Manufacturer AddressBURLINGTON MA 01803 US 01803


Patients

Patient NumberTreatmentOutcomeDate
10 2014-08-22

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