GAME READY INJURY TREATMENT SYSTEM 550550-03 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-12-21 for GAME READY INJURY TREATMENT SYSTEM 550550-03 NA manufactured by Coolsystems, Inc..

Event Text Entries

[16053217] The patient had bilateral anterior lateral fascia release surgery on (b)(6) 2012. He used the game ready injury treatment system with two half-leg boot wraps for 14 days 24/7 (alternating 30 minutes on and 30 minutes off, pressure and temperature unknown). During his first 2 post op appointments, (b)(6), his surgical incisions were showing good signs of healing with modest ecchymosis surrounding incisions without increased erythema, mild edema, and no exudate or increased warmth. On (b)(6) he had some exudate and necrotic tissue that resembles frostbite. Cultures were taken and patient was admitted to hospital for iv antibiotics and dry dressing changes. Cultures came back growing staph aureus and acinetobacter. The patient was discharged from hospital on (b)(6), on bactrim and dry dressing changes. Patient was seen in clinic on (b)(6), with no purulent drainage, but he did have some maceration of his wounds. The erythema and swelling had improved since the previous visit on (b)(6).
Patient Sequence No: 1, Text Type: D, B5


[16428450] There is a second patient that had the same surgery on (b)(6), whose wounds were starting to present with the same type of ecchymosis around the incisions 14 days after surgery. Coolsystems has not been provided with any additional information at this point. Nurse (b)(6) stated that there could be any number of factors that have contributed to this patient's outcome. They are still very happy with the game ready system and intend to continue to use them. The same game ready control unit, sn (b)(4) with a half leg boot wrap had been used on another patient after ankle surgery in september with no incident. Coolsystems has requested the game ready system to be sent in for evaluation. As of today, we have not received the asset.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2954777-2012-00002
MDR Report Key2888595
Report Source05
Date Received2012-12-21
Date of Report2012-11-29
Date of Event2012-11-28
Date Mfgr Received2012-11-29
Device Manufacturer Date2011-07-01
Date Added to Maude2012-12-31
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 ContactARLENE ALVAREZ
Manufacturer Street1800 SUTTER ST. SUITE 500
Manufacturer CityCONCORD CA 94520
Manufacturer CountryUS
Manufacturer Postal94520
Manufacturer Phone5109845351
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 Received2012-12-21
Model Number550550-03
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOLSYSTEMS, INC.
Manufacturer AddressCONCORD CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2012-12-21

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