MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-06-14 for GAME READY INJURY TREATMENT SYSTEM manufactured by Coolsystems, Inc..
[1539409]
Law suit (complaint) alleges use of cold therapy unit (ctu) by pt (plaintiff) between (b) (6) 2007 and (b) (6) 2008 resulted in unspecified personal injuries to her left knee.
Patient Sequence No: 1, Text Type: D, B5
[8622222]
The manufacturer has no direct knowledge of this complaint beyond what was reported in the summons. The summons does not describe the nature of the injury other than to say "since ending the use of the ctu... [patient] discovered that the ctu caused [patient] personal injuries. " no report of injury or product defect associated with this pt has been received by the manufacturer other than this summons. The device model number and serial number have not been identified to the manufacturer and the device was not returned to the manufacturer, so no evaluation could be conducted. Similarly, the distributor (the entity that owns/controls the asset) of the device is unk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2954777-2010-00002 |
| MDR Report Key | 1728330 |
| Report Source | 00 |
| Date Received | 2010-06-14 |
| Date of Report | 2010-06-04 |
| Date of Event | 2007-12-20 |
| Date Mfgr Received | 2010-06-04 |
| Date Added to Maude | 2010-06-21 |
| 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 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 INJURY TREATMENT SYSTEM |
| Generic Name | 890.5650/890.5720 (IRP/ILO) |
| Product Code | IRP |
| Date Received | 2010-06-14 |
| Operator | OTHER |
| 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. Other | 2010-06-14 |