D
Patient 1
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.
MAUDE MDR 1728330
- MDR report key
- 1728330
- Report number
- 2954777-2010-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2007-12-20
- Date received
- 2010-06-14
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MARIANNE BALDWIN
- Address
- 1201 MARINA VILLAGE PARKWAY STE. 200 ALAMEDA CA 94501 US
- Phone
- 510-510-5108
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | GAME READY INJURY TREATMENT SYSTEM | 890.5650/890.5720 (IRP/ILO) | COOLSYSTEMS, INC. | IRP | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2010-06-14 | 0 | 1. O |
Event Narratives#
N
Patient 1
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.