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 health professional,user faci report with the FDA on 2019-07-12 for UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM 001388LX9 manufactured by Integra York, Pa Inc..

MAUDE Entry Details

Report Number2523190-2019-00092
MDR Report Key8785674
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-07-12
Date of Report2019-06-18
Date of Event2019-06-17
Date Mfgr Received2019-07-11
Date Added to Maude2019-07-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactUSER KIMBERLY SHELLY
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 Received2019-07-12
Returned To Mfg2019-06-21
Catalog Number001388LX9
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
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 2019-07-12

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