Game Ready GRPRO 2.1 Control Unit Rental 550550-03-RNRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812120003812), received between May 15, 2024 and Nov 7, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequate Instructions for Non-Healthcare Professional” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2024Inadequate Instructions for Non-Healthcare Professional; Adverse Event Without Identified Device or Use Problem; Inadequate Instructions for Non-Healthcare Professional; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, "I'VE BEEN VERY DISAPPOINTED WITH THE COMPRESSION FEATURE. EVEN THOUGH THERE IS A MANUAL SETTING, THERE IS NO WAY TO MANUALLY INCREASE OR DECREASE THE TENSION IN THE COMPRESSION. THE COMPRESSION IS PAINFULLY INTENSE AT MEDIUM AND THE JACKET CONTINUES TO PUSH HARDER AND HARDER, NEVER REACHING ITS GOAL. TWO NIGHTS AGO, IT CAUSED ME SO MUCH PAIN THAT I WOUND UP IN THE EMERGENCY ROOM (ER) WITH NECK SPASMS. BUT FROM MY PERSPECTIVE THE SHOULDER JACKET PIECE IS DEFECTIVE BECAUSE IT'S UNABLE TO DETECT HOW MUCH PRESSURE IT IS PLACING ON MY SURGICAL REPAIRS. ". PER ADDITIONAL INFORMATION RECEIVED ON 23OCT2024, PATIENT IS POST-RIGHT ROTATOR CUFF SURGERY. AFTER 4-5 DAYS OF SITTING AND SLEEPING IN RECLINER, PATIENT FELT TREMENDOUS PRESSURE, STRAIN, AND SPASMS ON HIS NECK AND WAS UNABLE SWALLOW OR TURN HIS HEAD WITHOUT SEVERE PAIN. HE WENT TO EMERGENCY ROOM (ER) AND RECEIVED MUSCLE RELAXERS WHICH HELPED QUICKLY. PATIENT FEELS THAT THE WRAP DID NOT COME WITH ENOUGH INSTRUCTIONS ON GETTING THE VELCRO EXACTLY RIGHT TO AVOID THE EXCESS COMPRESSION ON SURGICAL SITES. PATIENT WAS REPORTED TO BE FEELING MUCH BETTER NOW.

  Patient problems: Cramp(s) /Muscle Spasm(s); Neck Pain

  MAUDE report 20629207 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, PATIENT DEVELOPED A SEVERE RED RAISE PAINFUL RASH WHICH STARTED ON (B)(6) 2024. SHE WAS USING THE GAME READY WRAP FOR 10-12 HOURS A DAY ON PROGRAM 1 AND 2. SHE HAD SHORTS ON WHEN USING AND WRAP WAS PLACE ON TOP OF SHIRTS. SHE WAS SEEN BY A DERMATOLOGIST AND PRESCRIBED ANTIHISTAMINE AND CORTISONE CREAM. SHE HAS DISCONTINUED THE GAME READY THERAPY AND SENT BACK DEVICE. PER ADDITIONAL INFORMATION RECEIVED ON 25-APR-2024, THE GAME READY THERAPY BEGAN ON (B)(6) 2024 (ONE DAY AFTER SURGERY). THE RASH WAS DISCOVERED BY THE PATIENT WHILE DURING USE ON (B)(6) 2024. LOCATION OF THE RASH WAS ON THE SIDE AND BACK OF THE LEFT HIP, LEFT BUTTOCK AND LEG ABOVE THE KNEE. ONLY THE LEFT LEG WAS AFFECTED. PATIENT¿S PRIMARY CARE PHYSICIAN PRESCRIBED ALLEGRA 180 MG ONCE A DAY AND TRIAMCINOLONE .1% CREAM 2 TIMES DAILY. PATIENT STARTED USING PRESCRIPTIONS THE DAY IT WAS PRESCRIBED, (B)(6) 2024 AND CONTINUES ON THE MEDICATION. THE UPPER PORTION OF THE RASH (FIRST TO APPEAR) IS FADED MOSTLY TO NICKLE-SIZED LIGHT PURPLE ROUNDS (IN A GRID) AND THE LOWER PORTION STILL HAS LARGE DARKER PURPLE BLOTCHES WITH 12 RED TO ORANGE LESIONS, SLOWLY IMPROVING.

  Patient problems: Erythema; Pain; Rash

  MAUDE report 19321022 ↗