SWIVEL ASSEMBLY STANDARD 437A2400

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 2019-09-08 for SWIVEL ASSEMBLY STANDARD 437A2400 manufactured by Integra Lifesciences Corporation Oh/usa.

MAUDE Entry Details

Report Number3004608878-2019-00745
MDR Report Key8973359
Report SourceUSER FACILITY
Date Received2019-09-08
Date of Report2019-08-26
Date Mfgr Received2019-08-26
Date Added to Maude2019-09-08
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 CORPORATION OH/USA
Manufacturer Street4900 CHARLEMAR DRIVE
Manufacturer CityCINCINNATI OH 45227
Manufacturer CountryUS
Manufacturer Postal Code45227
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSWIVEL ASSEMBLY STANDARD
Generic NameMAYFIELD FIELD REPLACABLE PARTS
Product CodeFWZ
Date Received2019-09-08
Returned To Mfg2018-05-10
Catalog Number437A2400
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA LIFESCIENCES CORPORATION OH/USA
Manufacturer Address4900 CHARLEMAR DRIVE 4900 CHARLEMAR DRIVE CINCINNATI OH 45227 US 45227


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-08

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