MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-03-10 for GAME READY INJURY TREATMENT SYSTEM manufactured by Coolsystems, Inc..
[20831064]
The identity of the device used by the pt is not known to the mfr, nor it is known to us who has possession of the device. No prior report of injury or product defect associated with this pt has been reported to the mfr other than this (b)(6). A thorough investigation will be conducted of this complaint and, as more info becomes available to the mfr, it will be communicated through this reporting process.
Patient Sequence No: 1, Text Type: N, H10
[20842128]
A (b)(6) reports that the pt was prescribed the use of game ready by a "qualified medical provider" for an injury to pt's right knee that required medical treatment. Pt's attorney reported that following the use of game ready, the pt "discovered that the ctu [cryotherapy unit] caused [pt flores] personal injuries. " the nature of the injuries is not specified. The mfr has no direct knowledge of this event as it became known to us only with the service of the (b)(6). No injuries were reported to the mfr by this pt or rep of this pt other than this (b)(6). Because this matter is under litigation, it has been turned over to the mfr's legal counsel for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954777-2011-00001 |
| MDR Report Key | 2019475 |
| Report Source | 00 |
| Date Received | 2011-03-10 |
| Date of Report | 2011-03-10 |
| Date of Event | 2009-02-15 |
| Date Mfgr Received | 2011-02-11 |
| Date Added to Maude | 2011-03-18 |
| 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 | MARIANNE BALDWIN |
| Manufacturer Street | 1201 MARINA VILLAGE PARKWAY #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 INJURY TREATMENT SYSTEM |
| Generic Name | 890.5650/890.5720 IRP/ILO |
| Product Code | IRP |
| Date Received | 2011-03-10 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOLSYSTEMS, INC. |
| Manufacturer Address | ALAMEDA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-03-10 |