MAUDE Adverse Event Report: COOLSYSTEMS, INC. GAME READY SYSTEM; COLD - AND INTERMITTENT COMPRESSION

Device Problem Failure to Auto Stop (2938)

Patient Problem Injury (2348)

Event Date 11/09/2013

Event Type  Injury  

Event Description

Service of summons on (b)(6) 2015 was the manufacturer's first notice of this event.Plaintiff's counsel claims that game ready system caused serious injuries including serious pain and swelling of the knee; hematoma of the injured knee; requiring surgery; wound infection at operation site; extensive irrigation and debridement of skin and soft tissue at wound site infection; extensive wound care therapy; physical and mental pain and suffering.The complaint does not contain information about the therapy protocol prescribed by the plaintiff's physician (e.G.Duration of cold therapy sessions and breaks in between same, temperature setting, and compression level settings), the barrier placed between the wrap (applied accessory) and the patient's skin, instructions for use provided to the plaintiff about the device.Because the matter is in litigation, it has been turned over to the outside for further investigation.

Manufacturer Narrative

The alleged event came to coolsystems, inc.Attention via service of a summons and complaint for damages filed with the district of (b)(6).The complaint for damages was filed more than 1 year after the actual 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 its performance history was or which device to return for evaluation.

• Brand Name: GAME READY SYSTEM
• Type of Device: COLD - AND INTERMITTENT COMPRESSION
• Manufacturer (Section D): COOLSYSTEMS, INC.; concord CA
• Manufacturer Contact: arlene alvarez ; 1800 sutter street, ste 500; concord, CA 94520 ; 5109845351
• MDR Report Key: 4510114
• MDR Text Key: 5495346
• Report Number: 2954777-2015-00001
• Device Sequence Number: 1
• Product Code: IRP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability