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U.S. Department of Health and Human Services

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

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BIOVENTUS LLC GELSYN, SODIUM HYALURONATE ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
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.
 
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Brand NameGELSYN, SODIUM HYALURONATE
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
BIOVENTUS LLC
MDR Report Key12446241
MDR Text Key270995923
Report NumberMW5103779
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
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 Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/08/2021 Patient Sequence Number: 1
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