MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2015-02-11 for GAME READY SYSTEM manufactured by Coolsystems, Inc..
[5495346]
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.
Patient Sequence No: 1, Text Type: D, B5
[12825893]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2954777-2015-00001 |
| MDR Report Key | 4510114 |
| Report Source | 00 |
| Date Received | 2015-02-11 |
| Date of Report | 2015-01-12 |
| Date of Event | 2013-11-09 |
| Date Mfgr Received | 2015-01-12 |
| Date Added to Maude | 2015-02-13 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ARLENE ALVAREZ |
| Manufacturer Street | 1800 SUTTER STREET, STE 500 |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal | 94520 |
| Manufacturer Phone | 5109845351 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAME READY SYSTEM |
| Generic Name | COLD - AND INTERMITTENT COMPRESSION |
| Product Code | IRP |
| Date Received | 2015-02-11 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOLSYSTEMS, INC. |
| Manufacturer Address | CONCORD CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-02-11 |