MAUDE Adverse Event Report: DJO, LLC DONJOY ICEMAN CLEAR3; PACK, HOT OR COLD, WATER CIRCULATING

Model Number SKU DJ-11-0493

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Local Reaction (2035); Urticaria (2278)

Event Type  Injury  

Event Description

While using donjoy iceman clear3 device, developed severe hives where device cooling pads came in contact with skin.Tried to upload pictures and not allowing me to do so.Fda safety report id# (b)(4).

• Brand Name: DONJOY ICEMAN CLEAR3
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): DJO, LLC
• MDR Report Key: 12276631
• MDR Text Key: 265358009
• Report Number: MW5102995
• Device Sequence Number: 1
• Product Code: ILO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SKU DJ-11-0493
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR