MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-10-28 for GAME READY INJURY TREATMENT SYSTEM manufactured by Coolsystems, Inc..
[1758032]
A summons reports that the pt was prescribed the use of game ready by a "qualified medical provider" for an injury to his right shoulder that required medical treatment. Pt reported to his attorney that following the use of game ready, he "discovered that the ctu [cryotherapy unit] caused [him] 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 summons. No injuries were reported to the mfr by this pt or rep of this pt other than this summons. 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
[8894578]
The identity of the device used by the pt is known to the mfr because this pt was served by the mfr through an independent rep. At the time the service was provided and following the use of the device the pt did not report any problems to either the mfr or to the rep who set the pt up with the device. Because there was no knowledge of any problem the device has continued in service to other pts with no complaints since the date of the event (now a yr). Since there would be nothing that could be discovered in an eval of the physical device that could be tracked back to its use by an specific pt 1 yr ago, the device was not brought back to the mfr for eval. However, the service records for the device and the complaint records were searched for events related to this device and nothing was found to indicate product defect or pt injury. No prior report of injury or product defect associated with this pt has been reported to the mfr other than this summons. 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
| Report Number | 2954777-2010-00005 |
| MDR Report Key | 1890122 |
| Report Source | 00 |
| Date Received | 2010-10-28 |
| Date of Report | 2010-10-27 |
| Date of Event | 2009-10-13 |
| Date Mfgr Received | 2010-10-12 |
| Device Manufacturer Date | 2007-06-12 |
| Date Added to Maude | 2010-11-05 |
| 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 | 2010-10-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2010-10-28 |