Game Ready 550500-03Recalls & reported problems
Avanos Medical, Inc. · Control Unit GRPro 2.1 System · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812120000514), received between Aug 15, 2019 and Aug 15, 2019 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Scarring1
- Superficial (First Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD KNEE SURGERY ON (B)(6) 2018 AND USED THE GAME READY IMMEDIATELY AFTER SURGERY THAT DAY. HE WAS TOLD BY THE DOCTOR TO FOLLOW A 30 MINUTES ON / 30 MINUTES OFF PROTOCOL WITH FULL COLD (34 DEGREES), LOW COMPRESSION (5-15MMHG), WEARING A STOCKINET. PATIENT TOOK UNSPECIFIED PAIN MEDICATIONS 36 HOURS AFTER SURGERY. ON POST OP DAY 3 PATIENT REPORTS EXPERIENCING A SHARP PAIN ON HIS SHIN AND ALSO PRESENTS WITH A PRONOUNCED AREA OF REDNESS ON HIS SHIN. HE STATES THE PAIN MEDICATIONS HAD WORN OFF AT THIS POINT. PATIENT QUITS USING THE GAME READY AND VISITS THE DOCTOR ON POST OP DAY 4. THE PATIENT STATES THAT THE DOCTOR IS CONCERNED ABOUT THE BURN AREA ON HIS SHIN TO STOP USING THE GAME READY AND THAT THE GAME READY MAY HAVE CONTRIBUTED TO THE BURN. COOLSYSTEMS, INC. WAS NOTIFIED OF THIS ALLEGED INJURY ON (B)(6) 2019 BY THE DISTRIBUTOR, WHO WAS CONDUCTING AN INVESTIGATION TO DETERMINE IF THE GAME READY COULD HAVE CONTRIBUTED TO THE ALLEGED INJURY. COOLSYSTEMS, INC. INTERVIEWED THE PATIENT ON (B)(6) 2019 AND THE PATIENT REPORTED THAT HE'S NO LONGER RECEIVING CARE FOR THE ALLEGED INJURY AND STATED THAT HE IS EXPERIENCING SCARRING.
Patient problems: Scarring; Superficial (First Degree) Burn
MAUDE report 8897617 ↗
Other Pack, Hot Or Cold, Water Circulating devices
- DONJOY 11-0494Djo, LLC · Pack, hot or cold, water circulating1 recall1 report
- DONJOY 11-1422Djo, LLC · Pack, hot or cold, water circulating1 recall1 report
- DONJOY 11-9099Djo, LLC · Pack, hot or cold, water circulating1 recall0 reports
- Electri-Cool ll 767Gentherm Medical, LLC · Pack, Hot Or Cold, Water Circulating1 recall0 reports
- Micro-Temp LT 749Gentherm Medical, LLC · Pack, Hot Or Cold, Water Circulating1 recall0 reports
- DONJOY 11-1424Djo, LLC · Pack, hot or cold, water circulating1 recall0 reports
- T/Pump TP700Stryker Corporation · Pack, hot or cold, water circulating15 reports
- Mul-T-Pad 8002-062-026Stryker Corporation · Pack, hot or cold, water circulating7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page