MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-06-13 for GAME READY SYSTEM 500055 manufactured by Coolsystems, Inc..
[869614]
The pt underwent bunionectomy surgery in 2007 and post-operative therapy with elevation and cryotherapy with game ready. The pt developed bruising on the tip of her toe that was noted 7 days post-surgery. At 10 days post-surgery, she was found to have cyanosis and severe swelling of her lower extremity, which progressed to toe necrosis. She also had circumferential anesthesia from the level of the ankle to the toes. The surgeon performed a 2nd surgery ten days later. The pt subsequently responded to sympathetic nerve blocks and had a partial amputation of the great toe by plastic surgeon and continued to heal uneventfully. There was no report of device malfunction and the surgeon considered this a bad outcome of the surgery and not a complaint or adverse event associated with game ready. A bunionectomy pt developed classic symptoms of reflex sympathetic dystrophy (rsd), also known as complex regional pain syndrome (crps). The surgeon concluded that the ten days prior to original date pt may have had rsd and that possibly the use of game ready had contributed to these events. The surgeon was uncertain of the relationship to our product, so asked our distributor if there were other rsd cases with game ready users. Initial contact from distributor on may 7, 2008 was a request for info, not a complaint. The question was whether or not we had prior reports of rsd because one of his customers believed he had two such cases and because his surgical procedure was unchanged, wondered if it was associated with his newly adopted use of game ready in his post-op management regime. There was no report of device malfunction. We know that approx. 1. 2 million pts have used game ready in 6 years with no prior reports of rsd. Of note, an ankle wrap was used on this bunionectomy pt and it does not cover the toes.
Patient Sequence No: 1, Text Type: D, B5
[8018644]
Rsd/crps is a syndrome with varied symptoms and severity, but generally represented by widespread pain. It is reported to have multiple possible causes and no known "cure", although cryotherapy is often used to help manage the pain. Thus, we did not initially consider this a complaint or adverse event. However, we did follow up with our chief medical advisor, a physiatrist, on that same day and he also did not believe that the use of game ready could lead to the development of crps. At our request, he contacted the surgeon directly, to follow up with him. On may 22, 2008, we were told that the surgeon had reported the pt symptoms described, which clearly represent an injury that should be reported within 30 days, regardless of relatedness. The game ready system used by this pt performed as intended and because this is not a single-use device and there was no device malfunction, it was put back into the rental fleet of the distributor for use with other pts before we could request its return and has continued to be used without incident or malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2954777-2008-00001 |
| MDR Report Key | 1060883 |
| Report Source | 08 |
| Date Received | 2008-06-13 |
| Date of Report | 2008-05-22 |
| Date of Event | 2007-11-30 |
| Date Mfgr Received | 2008-05-22 |
| Device Manufacturer Date | 2007-09-01 |
| Date Added to Maude | 2008-06-23 |
| 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 PKWY STE. 200 |
| Manufacturer City | ALAMEDA CA 94501 |
| Manufacturer Country | US |
| Manufacturer Postal | 94501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAME READY SYSTEM |
| Generic Name | 890.5650 IRP ILO |
| Product Code | IRP |
| Date Received | 2008-06-13 |
| Model Number | 500055 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1029637 |
| Manufacturer | COOLSYSTEMS, INC. |
| Manufacturer Address | ALAMEDA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2008-06-13 |