SELECTOR INTEGRA USA 1530000M3

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2008-02-15 for SELECTOR INTEGRA USA 1530000M3 manufactured by Integra Neurosciences, Ltd..

Event Text Entries

[794299] Integra received notice that the device was used in a surgical procedure in 2005. As a result, pt injury has been alleged. This incident is being further investigated.
Patient Sequence No: 1, Text Type: D, B5


[8092381] The device involved in the reported incident is expected to be available for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8010219-2008-00001
MDR Report Key998851
Report Source00
Date Received2008-02-15
Date of Report2008-02-15
Date Mfgr Received2008-01-18
Date Added to Maude2008-02-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationATTORNEY
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactLINDA GOODSTEIN
Manufacturer Street311C ENTERPRISE DR
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362269
Manufacturer G1INTEGRA NEUROSCIENCES, LTD.
Manufacturer StreetNEWBURY RD.
Manufacturer CityANDOVER HAMPSHIRE SP104DR
Manufacturer Postal CodeSP104DR
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSELECTOR INTEGRA USA
Generic NameNONE
Product CodeLBK
Date Received2008-02-15
Catalog Number1530000M3
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key968644
ManufacturerINTEGRA NEUROSCIENCES, LTD.
Manufacturer AddressANDOVER HAMPSHIRE


Patients

Patient NumberTreatmentOutcomeDate
10 2008-02-15

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