MAUDE Adverse Event Report: AVANOS MEDICAL INC. GAME READY CONTROL SYSTEM - GRPRO 2.1

Model Number	550550-03-RN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Rash (2033)
Date of Event	04/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.A root cause could not be determined.All information reasonably known as of 14 may 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
Event or Problem Description
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.
Additional Manufacturer Narrative
All information reasonably known as of 07 jul 2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(6).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

• Brand Name: GAME READY CONTROL SYSTEM - GRPRO 2.1
• Common Device Name: GRPRO
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): PRIDE INDUSTRIES; 10030 foothills blvd; roseville CA 95747
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 19321022
• Report Number: 3011270181-2024-00056
• Device Sequence Number: 6338906
• Product Code: IRP
• UDI-Device Identifier: 00812120003812
• UDI-Public: 00812120003812
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K192114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 550550-03-RN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 06/07/2025
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 58 KG