RETROGUARD ARTERIAL SAFTEY VALVE 4007200 *

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 2006-11-30 for RETROGUARD ARTERIAL SAFTEY VALVE 4007200 * manufactured by Quest Medical, Inc..

Event Text Entries

[580075] The customer reported that they found a crack in the retroguard body. Twelve samples were saved and will be returned to quest. Product code 4007200; lot number 24724.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1649914-2006-00140
MDR Report Key794190
Report Source00
Date Received2006-11-30
Date of Report2006-11-29
Date Mfgr Received2006-11-14
Device Manufacturer Date2005-08-01
Date Added to Maude2006-12-15
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 Location0
Manufacturer ContactMEGAN SIMS
Manufacturer StreetONE ALLENTOWN PARKWAY
Manufacturer CityALLEN TX 75002
Manufacturer CountryUS
Manufacturer Postal75002
Manufacturer Phone9723909800
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRETROGUARD ARTERIAL SAFTEY VALVE
Generic NameFLOW CHECK VALVE
Product CodeMJJ
Date Received2006-11-30
Model Number4007200
Catalog Number*
Lot Number24724
ID Number*
Device Expiration Date2015-08-27
OperatorOTHER
Device AvailabilityY
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key781811
ManufacturerQUEST MEDICAL, INC.
Manufacturer AddressONE ALLENTOWN PKWY. ALLEN TX 75002 US
Baseline Brand NameRETROGUARD
Baseline Generic NameFLOW CHECK VALVE
Baseline Model No4007200
Baseline Catalog No*
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
10 2006-11-30

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