MAUDE Adverse Event Report: DJO GLOBAL CHATTANOOGA VECTA GENISYS COLD LASER THERAPY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 05/02/2017

Event Type  Injury  

Event Description

I went for physical therapy, he/she treated me with cold laser therapy, after therapy i feel more pain and burning at spot of therapy, may be they hold it too long at one spot.

• Brand Name: CHATTANOOGA VECTA GENISYS COLD LASER THERAPY
• Type of Device: CHATTANOOGA VECTA GENISYS COLD LASER THERAPY
• Manufacturer (Section D): DJO GLOBAL
• MDR Report Key: 6553873
• MDR Text Key: 74905852
• Report Number: MW5069640
• Device Sequence Number: 0
• Product Code: ILY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 43