MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. MONOVISC; SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION

Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Irritation (1941)
Date of Event	03/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Updates provided: on 28sep2018: patient was admitted to the hospital on (b)(6) 2018 and treated for hives with an epipen and an iv drip of epinephrine.On 23oct18: patient states that he continues to experience hives.He is currently taking allergy medication that does not seem to improve his condition.
Event or Problem Description
"i received a call from (b)(6) on behalf of her son, (b)(6), who was injected with monovisc on (b)(6) 2018 (usa).Around (b)(6) 2018, (b)(6) started getting "chronic hives" (idiopathic urticaria) and she believes that the hives were a result of the monovisc injection.Can someone please follow up with (b)(6): (b)(6).".

• Brand Name: MONOVISC
• Common Device Name: SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 7996590
• Report Number: 3007093114-2018-00012
• Device Sequence Number: 19276127
• Product Code: MOZ
• UDI-Device Identifier: 10886705025183
• UDI-Public: 10886705025183
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P090031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 25 YR