GAME READY INJURY TREATMENT SYSTEM

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 2012-04-19 for GAME READY INJURY TREATMENT SYSTEM manufactured by Coolsystems, Inc..

Event Text Entries

[2808112] A summons received on (b)(6) 2012 reports that the pt was prescribed the use of game ready for an injury to pt's right knee that required medical treatment. Pt's attorney reported that following the use of game ready, the pt "discovered that the ctu [cryotherapy unit] caused [patient] personal injuries. " the nature of the injuries is not specified. The mfr has no direct knowledge of this event as it became known to us only with the service of the summons. No injuries were reported to the mfr by this pt or representative of this pt other than this summons. Because this matter is under litigation, it has been turned over to the mfr's legal counsel for investigation.
Patient Sequence No: 1, Text Type: D, B5


[9960022] The identity of the device used by the pt is not known to the mfr nor is it known who has possession of the device. No prior report of injury or product defect associated with this pt has been reported to the mfr other than this summons. A thorough investigation will be conducted of this complaint and, as more info becomes available to the mfr, it will be communicated through this reporting process.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2954777-2012-00001
MDR Report Key2546702
Report Source00
Date Received2012-04-19
Date of Report2012-04-19
Date of Event2010-12-03
Date Mfgr Received2012-04-11
Date Added to Maude2012-04-25
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 FDA0
Event Location0
Manufacturer ContactMARIANNE BALDWIN
Manufacturer Street1800 SUTTER STREET #500
Manufacturer CityCONCORD CA 94520
Manufacturer CountryUS
Manufacturer Postal94520
Manufacturer Phone5108685378
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGAME READY INJURY TREATMENT SYSTEM
Generic Name890.5650/890.5720 IRP/ILO
Product CodeIRP
Date Received2012-04-19
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCOOLSYSTEMS, INC.
Manufacturer AddressCONCORD CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2012-04-19

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