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..
[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
| Report Number | 2954777-2010-00001 |
| MDR Report Key | 1659010 |
| Report Source | 00 |
| Date Received | 2010-04-13 |
| Date of Report | 2010-04-12 |
| Date of Event | 2008-04-05 |
| Date Mfgr Received | 2010-04-08 |
| Date Added to Maude | 2010-04-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIANNE BALDWIN |
| Manufacturer Street | 1201 MARIANA VILLAGE PARKWAY STE. 200 |
| Manufacturer City | ALAMEDA CA 94501 |
| Manufacturer Country | US |
| Manufacturer Postal | 94501 |
| Manufacturer Phone | 5108685378 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAME READY SYSTEM |
| Generic Name | 890.5650/890.5720 IRP/ILO |
| Product Code | IRP |
| Date Received | 2010-04-13 |
| Model Number | 550100 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOLSYSTEMS, INC. |
| Manufacturer Address | ALAMEDA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-04-13 |