DURASEAL SPINE OUS 3ML KIT 1KIT/BOX CE APPROVED 203001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-07-12 for DURASEAL SPINE OUS 3ML KIT 1KIT/BOX CE APPROVED 203001 manufactured by Integra Lifesciences Corp.

MAUDE Entry Details

Report Number3003418325-2019-00023
MDR Report Key8785678
Report SourceFOREIGN,USER FACILITY
Date Received2019-07-12
Date of Report2019-06-28
Date of Event2019-04-29
Date Mfgr Received2019-09-19
Device Manufacturer Date2018-08-29
Date Added to Maude2019-07-12
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 ContactMRS. KIMBERLY SHELLY
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362319
Manufacturer G1INTEGRA LIFESCIENCES CORP
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal Code08536
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDURASEAL SPINE OUS 3ML KIT 1KIT/BOX CE APPROVED
Generic NameDURASEAL SPINE
Product CodeNQR
Date Received2019-07-12
Returned To Mfg2019-08-21
Catalog Number203001
Lot NumberN8HC891X
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA LIFESCIENCES CORP
Manufacturer Address311 ENTERPRISE DRIVE 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-12

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