MAUDE Adverse Event Report: ROOSTER COMB INJECTION; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problems Pain (1994); Concussion (2192); Loss of consciousness (2418); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

After receiving two shots, 1 in knee, i came home and went to bed.I woke up early and stood.I had excruciating pain in my legs and passed out.After passing out my daughter heard me scream and pulled me back in bed.I couldn't stand or walk.I wasn't able to walk to stand for over a week.I hit my head on the dresser when i passed out, i had a concussion.Didn't remember many things.Drs refused to give me data from that day.Don't know.Quantity: 2 shots, injected in both knees.Date: can't remember.Reason for use: lubricate my knees for pain.Duration: 1 day.I can barely walk now.

• Brand Name: ROOSTER COMB INJECTION
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• MDR Report Key: 11776816
• MDR Text Key: 249424073
• Report Number: MW5101173
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 04/27/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 70 YR
• Patient Weight: 77