MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-12-21 for GAME READY INJURY TREATMENT SYSTEM 550550-03 NA manufactured by Coolsystems, Inc..
[16053217]
The patient had bilateral anterior lateral fascia release surgery on (b)(6) 2012. He used the game ready injury treatment system with two half-leg boot wraps for 14 days 24/7 (alternating 30 minutes on and 30 minutes off, pressure and temperature unknown). During his first 2 post op appointments, (b)(6), his surgical incisions were showing good signs of healing with modest ecchymosis surrounding incisions without increased erythema, mild edema, and no exudate or increased warmth. On (b)(6) he had some exudate and necrotic tissue that resembles frostbite. Cultures were taken and patient was admitted to hospital for iv antibiotics and dry dressing changes. Cultures came back growing staph aureus and acinetobacter. The patient was discharged from hospital on (b)(6), on bactrim and dry dressing changes. Patient was seen in clinic on (b)(6), with no purulent drainage, but he did have some maceration of his wounds. The erythema and swelling had improved since the previous visit on (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[16428450]
There is a second patient that had the same surgery on (b)(6), whose wounds were starting to present with the same type of ecchymosis around the incisions 14 days after surgery. Coolsystems has not been provided with any additional information at this point. Nurse (b)(6) stated that there could be any number of factors that have contributed to this patient's outcome. They are still very happy with the game ready system and intend to continue to use them. The same game ready control unit, sn (b)(4) with a half leg boot wrap had been used on another patient after ankle surgery in september with no incident. Coolsystems has requested the game ready system to be sent in for evaluation. As of today, we have not received the asset.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2954777-2012-00002 |
| MDR Report Key | 2888595 |
| Report Source | 05 |
| Date Received | 2012-12-21 |
| Date of Report | 2012-11-29 |
| Date of Event | 2012-11-28 |
| Date Mfgr Received | 2012-11-29 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2012-12-31 |
| 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 | 1800 SUTTER ST. 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 INJURY TREATMENT SYSTEM |
| Generic Name | 890.5650/890.5720 IRP/ILO |
| Product Code | IRP |
| Date Received | 2012-12-21 |
| Model Number | 550550-03 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Other | 2012-12-21 |