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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. MONOVISC; ACID, HYALURONIC, INTRAARTICULAR
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ANIKA THERAPEUTICS, INC. MONOVISC; ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Patient Problems Fever (1858); Nausea (1970); Pain (1994); Chills (2191); Arthralgia (2355); Ambulation Difficulties (2544)
Event Date 01/23/2024
Event Type  Injury  
Event Description
Reporter calling, stating she experienced adverse reactions after monovisc injection in her left knee.Reporter states she was injected with monovisc on (b)(6) 2024, and approximately five hours after injection, reporter states her knee joint "locked", was painful, and she was only able to limp around.Reporter states approximately seven hours after injection, she developed chills, shaking/tremors, a fever of "103 degrees", nausea and intense back pain.Reporter states that approximately twenty-four hours after injection, her fever was still elevated at "101 degrees".Reporter states that today, (b)(6) 2024, the fever has broken and her knee joint is "moving much better".Reporter expresses concern over her symptoms during the previous forty-eight hours and states that when she searched online for potential adverse reactions to monovisc, very few symptoms or side effects are listed.Reporter expresses her concern over the symptoms she experienced and is filing a report so that others may be warned to the potential side effects of monovisc.
 
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Brand Name
MONOVISC
Type of Device
ACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
ANIKA THERAPEUTICS, INC.
MDR Report Key18588386
MDR Text Key333962959
Report NumberMW5150748
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Patient Sequence Number1
Patient Age60 YR
Patient SexFemale
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