MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2015-07-28 for GAME READY SYSTEM manufactured by Coolsystems, Inc..
[6036316]
Service of summons on 07/24/2015 was the manufacturer's first notice of this event. The plaintiff was prescribed a game ready system on (b)(6) 2013 by her physician as postoperative treatment following the removal of a bunion on her left foot. During a follow up visit on 09/10/2013, the plaintiff complained of some discoloration on her foot, received treatment, and discontinued the use of the game ready system per her physician's recommendation. The condition of the foot worsened, eventually resulting in gangrene, and ultimately a partial amputation of her foot. 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 setting), 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 counsel for further investigation.
Patient Sequence No: 1, Text Type: D, B5
[13707611]
The alleged event came to coolsystems, inc. Attention via service of a summons and complaint for damages filed with the superior court of (b)(6), county of (b)(6). The complaint for damages was filed almost 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 its performance history was or which device to return for evaluation. This is why the evaluation codes were chosen.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2954777-2015-00002 |
| MDR Report Key | 4951509 |
| Report Source | 00 |
| Date Received | 2015-07-28 |
| Date of Report | 2015-07-24 |
| Date of Event | 2013-09-10 |
| Date Mfgr Received | 2015-07-24 |
| Date Added to Maude | 2015-07-31 |
| 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 | 180 0SUTTER STREET, SUITE 500 |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal | 94520 |
| Manufacturer Phone | 5109845351 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAME READY SYSTEM |
| Generic Name | COLD- AND INTERMITTENT COMPRESSION |
| Product Code | IRP |
| Date Received | 2015-07-28 |
| 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 | CONCORD CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-07-28 |