STANDARD WISHBONE ASSEMBLY 4020

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-08-25 for STANDARD WISHBONE ASSEMBLY 4020 manufactured by Integra Lifesciences Corporation Oh/usa.

Event Text Entries

[83687477] 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


[83687478] Customer initially reports omni devices not holding. No injury to the patient any other patient information unknown. Two of 2.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2125289-2017-00012
MDR Report Key6821045
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2017-08-25
Date of Report2017-07-26
Date of Event2017-07-24
Date Mfgr Received2017-08-28
Device Manufacturer Date2015-12-01
Date Added to Maude2017-08-25
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 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 NameSTANDARD WISHBONE ASSEMBLY
Generic NameSURGICAL RETRACTOR
Product CodeFFO
Date Received2017-08-25
Returned To Mfg2017-08-15
Catalog Number4020
Lot Number159
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 2017-08-25

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