MAUDE Adverse Event Report: COOLSYSTEMS, INC. GAME READY AND KNEE WRAP, GAME READY / COOL SYSTEMS; PACK, HOT OR COLD, WATER CIRCULATING

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2019

Event Type  malfunction  

Event Description

Product did not state that it contained latex.Latex allergy.Fda safety report id# (b)(4).

• Brand Name: GAME READY AND KNEE WRAP, GAME READY / COOL SYSTEMS
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): COOLSYSTEMS, INC.
• MDR Report Key: 8573584
• MDR Text Key: 144117029
• Report Number: MW5086329
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2019
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 107