Game Ready 590424-03-RNRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812120001474), received between Jan 27, 2023 and Jan 27, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED, THE PATIENT HAD A REACTION OF HIVES DURING USE OF THE GAME READY (GR) DEVICE. THE DOCTOR PRESCRIBED A TOPICAL STEROID CREAM, ON (B)(6) 2023, FOR CONTACT DERMATITIS TO THE ARMPIT AREA. THE PATIENT REPORTEDLY WORE THE GR SLEEVE ON PROGRAM 2 BECAUSE THE "SLEEVE WOULD NOT GET TIGHT ENOUGH WHEN ON PROGRAM 1". THE SLEEVE WAS WORN CONTINUOUSLY FROM (B)(6) 2022- (B)(6) 2023 WITH COMPRESSION 30 MINUTES ON AND THEN 30 MINUTES NO COMPRESSION. THE PATIENT¿S CURRENT CONDITION WAS NOT REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16256254 ↗