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 2010-10-28 for GAME READY INJURY TREATMENT SYSTEM manufactured by Coolsystems, Inc..

Event Text Entries

[1758032] A summons reports that the pt was prescribed the use of game ready by a "qualified medical provider" for an injury to his right shoulder that required medical treatment. Pt reported to his attorney that following the use of game ready, he "discovered that the ctu [cryotherapy unit] caused [him] 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 rep 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


[8894578] The identity of the device used by the pt is known to the mfr because this pt was served by the mfr through an independent rep. At the time the service was provided and following the use of the device the pt did not report any problems to either the mfr or to the rep who set the pt up with the device. Because there was no knowledge of any problem the device has continued in service to other pts with no complaints since the date of the event (now a yr). Since there would be nothing that could be discovered in an eval of the physical device that could be tracked back to its use by an specific pt 1 yr ago, the device was not brought back to the mfr for eval. However, the service records for the device and the complaint records were searched for events related to this device and nothing was found to indicate product defect or pt injury. 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 Number2954777-2010-00005
MDR Report Key1890122
Report Source00
Date Received2010-10-28
Date of Report2010-10-27
Date of Event2009-10-13
Date Mfgr Received2010-10-12
Device Manufacturer Date2007-06-12
Date Added to Maude2010-11-05
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 Street1201 MARINA VILLAGE PARKWAY #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 INJURY TREATMENT SYSTEM
Generic Name890.5650/890.5720 IRP/ILO
Product CodeIRP
Date Received2010-10-28
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCOOLSYSTEMS, INC.
Manufacturer AddressALAMEDA CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2010-10-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.