MAUDE Adverse Event Report: GEL-ONE INJECTION; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problems Pain (1994); Burning Sensation (2146); Loss of consciousness (2418); Confusion/ Disorientation (2553)

Event Date 07/03/2017

Event Type  Injury  

Event Description

I was scheduled to receive gel-one injections in both knees for arthritis-related knee problems.I lost consciousness right as the injection was completed.The last time i fainted was over 10 years ago.Although the shot was extremely painful.I do not believe the loss of consciousness was a result of the pain.My blood pressure is usually good, probably more on the low end of normal.I was also very confused and had trouble focusing after i was revived, but they used something ammonia-based to revive me.It caused a burning sensation inside my mouth; skin eventually peeled from under my nose.Confusion may have been related to that substance.Date of use: (b)(6) 2017."how was it taken or used: knee injection, did the problem returned if the person started taking or using the product again: no." the problem did not stop after the person reduced the dose or stopped taking or using the product.Knee pain related to arthritis.

• Brand Name: GEL-ONE INJECTION
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• MDR Report Key: 6794218
• MDR Text Key: 82775388
• Report Number: MW5071579
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• 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: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 79