MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-08-15 for GRPRO 2.1 AND STRAIGHT KNEE WRAP 550500-03 manufactured by Coolsystems, Inc. (dba Game Ready).
| Report Number | 2954777-2019-00002 |
| MDR Report Key | 8897617 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-08-15 |
| Date of Report | 2019-09-13 |
| Date of Event | 2019-09-20 |
| Date Mfgr Received | 2019-07-17 |
| Device Manufacturer Date | 2011-03-15 |
| Date Added to Maude | 2019-08-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ARLENE ALVAREZ |
| Manufacturer Street | 1800 SUTTER STREET SUITE 500 |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal | 94520 |
| Manufacturer Phone | 5109845351 |
| Manufacturer G1 | COOLSYSTEMS, INC. |
| Manufacturer Street | 1800 SUTTER STREET SUITE 500 |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94520 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRPRO 2.1 AND STRAIGHT KNEE WRAP |
| Generic Name | COLD- AND INTERMITTENT COMPRESSION |
| Product Code | ILO |
| Date Received | 2019-08-15 |
| Returned To Mfg | 2019-08-09 |
| Model Number | 550500-03 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOLSYSTEMS, INC. (DBA GAME READY) |
| Manufacturer Address | 1800 SUTTER STREET SUITE 500 CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-08-15 |