MAUDE Adverse Event Report: BIOVENTUS LLC GELSYN, SODIUM HYALURONATE; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Diarrhea (1811); Fatigue (1849); Itching Sensation (1943); Nausea (1970); Rash (2033); Arthralgia (2355); Unspecified Gastrointestinal Problem (4491); Unspecified Musculoskeletal problem (4535)

Event Date 08/31/2021

Event Type  Injury  

Event Description

Had gelsyn injections, second dose in both knees.Had muscle and joint pain, rash, itching, nausea, diarrhea, fatigue.After a week still having digestive problems and fatigue.

• Brand Name: GELSYN, SODIUM HYALURONATE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 12446241
• MDR Text Key: 270995923
• Report Number: MW5103779
• 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: 09/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• 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; Disability
• Patient Age: 70 YR
• Patient Weight: 61