GAME READY SYSTEM 550100

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 2010-04-13 for GAME READY SYSTEM 550100 manufactured by Coolsystems, Inc..

Event Text Entries

[17870979] Service of summons and complaint on april 08, 2010 was manufacturer's first notice of this event. Plaintiff's counsel claims in the complaint that game ready system caused injury and as a result, the plaintiff lost mobility requiring the use of a cane and/or wheel chair. He alleges that a game ready control unit was used from on or about (b) (6) 2008 to on or about (b) (6) 2008 post operatively on plaintiff's left ankle. On (b) (6) 2009, the plaintiff underwent an electromyogram, nerve conduction study which first revealed nerve damage to plaintiff's ankle, allegedly caused by game ready control unit. The complaint does not contain information about the therapy protocol prescribed by plaintiff's physician (e. G. Duration of cold therapy sessions and breaks in between same, temperature settings, and compression level settings), the barrier placed between the wrap (applied accessory) and the pt's skin, instructions for use provided to the plaintiff about the use of the device. Because the matter is in litigation, it has been turned over to the outside counsel for further investigation.
Patient Sequence No: 1, Text Type: D, B5


[17964484] The alleged event came to coolsystems, inc. Attention via service of summons and complaint for damages filed with the (b) (6) clerk of the superior court. The complaint for damages was filed with the (b) (6) about 2 years after the alleged event. A complaint was never reported to coolsystems, inc. And the game ready system involved in the event has not been identified. Thus, it cannot be determined what entity owns/controls the device in question, what its performance history was or which device to return for evaluation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2954777-2010-00001
MDR Report Key1659010
Report Source00
Date Received2010-04-13
Date of Report2010-04-12
Date of Event2008-04-05
Date Mfgr Received2010-04-08
Date Added to Maude2010-04-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Manufacturer ContactMARIANNE BALDWIN
Manufacturer Street1201 MARIANA VILLAGE PARKWAY STE. 200
Manufacturer CityALAMEDA CA 94501
Manufacturer CountryUS
Manufacturer Postal94501
Manufacturer Phone5108685378
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGAME READY SYSTEM
Generic Name890.5650/890.5720 IRP/ILO
Product CodeIRP
Date Received2010-04-13
Model Number550100
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOLSYSTEMS, INC.
Manufacturer AddressALAMEDA CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2010-04-13

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