ENHANCED EXTERNAL COUNTERPULSATION TS3. *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2003-09-03 for ENHANCED EXTERNAL COUNTERPULSATION TS3. * manufactured by Vasomedical Inc..

Event Text Entries

[331554] When patient started course of therapy (their 3rd coruse) they complained of leg cramps in the right leg. Could not tolerate full treatment pressure or complete a session with out breaking to relieve pain. Four consectuve days passed until patient returend for treatment, due to a vacation. After the next treatment, patient was reported to have been admitted to the hospital for an occlusive thrombus in the right leg.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2435600-2003-00010
MDR Report Key482196
Report Source07
Date Received2003-09-03
Date of Report2003-09-02
Date of Event2003-08-12
Date Mfgr Received2003-08-13
Device Manufacturer Date2001-06-01
Date Added to Maude2003-09-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactTHOMAS VARRICCHIONE
Manufacturer Street180 LINDEN AVE.
Manufacturer CityWESTBURY NY 11590
Manufacturer CountryUS
Manufacturer Postal11590
Manufacturer Phone5169974600
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENHANCED EXTERNAL COUNTERPULSATION
Generic NameDEVICE, COUNTER-PULSATING, EXTERNAL
Product CodeDRN
Date Received2003-09-03
Model NumberTS3.
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key471082
ManufacturerVASOMEDICAL INC.
Manufacturer Address180 LINDEN AVE. WESTBURY NY 11590 US
Baseline Brand NameENHANCED EXTERNAL COUNTERPULSATION
Baseline Generic NameDEVICE, COUNTER-PULSATING, EXTERNAL
Baseline Model NoTS3.
Baseline Catalog No*
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2003-09-03

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