MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. MONOVISC INJ 88MG/4ML; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problems Syncope (1610); Bruise/Contusion (1754); Fall (1848)

Event Date 04/11/2018

Event Type  Injury  

Event Description

Admit date: (b)(6) 2018, dc date: (b)(6) 2018, admit type: ip - medical intervention status: complete; (b)(6) 2018 - (b)(6) yo ip for fall d/t syncope no fx's.Stable w/bruising.Dx oa, last monovisc r shoulder (b)(6) 2018, no se's.(b)(6) 2018.(b)(6), rn (b)(6) 2018."is the product compounded: no; is the product over-the-counter: no.".

• Brand Name: MONOVISC INJ 88MG/4ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 7446388
• MDR Text Key: 106163200
• Report Number: MW5076574
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 59676082001
• UDI-Public: 59676082001
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR