UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM 001388LX9

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-12-10 for UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM 001388LX9 manufactured by Integra York, Pa Inc..

Event Text Entries

[95080159] 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


[95080160] Device got real hot on doctors headlight and fiber optics are showing through, the cable has separated from the adaptor. Customer not responding to several requests (3) for additional information.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2523190-2017-00149
MDR Report Key7103258
Report SourceUSER FACILITY
Date Received2017-12-10
Date of Report2017-11-17
Date Mfgr Received2017-12-12
Date Added to Maude2017-12-10
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 FDA3
Event Location3
Manufacturer ContactUSER SANDRA LEE
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1INTEGRA YORK, PA INC.
Manufacturer Street589 DAVIES DRIVE
Manufacturer CityYORK PA 17402
Manufacturer CountryUS
Manufacturer Postal Code17402
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUL PRO FUSED HEADLIGHT CABLE 9FT, 275CM
Generic NameCABLES
Product CodeFST
Date Received2017-12-10
Catalog Number001388LX9
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA YORK, PA INC.
Manufacturer Address589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402


Patients

Patient NumberTreatmentOutcomeDate
10 2017-12-10

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