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

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2019

Event Type  Injury  

Event Description

Mdo called in stating they received 4 pfs of monovisc instead of 1.Order was entered correctly in the system.Fulfillment sent out incorrect qty.Mdo will send back the add'l pfs.

• Brand Name: MONOVISC INJ 88MG/4ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 8623722
• MDR Text Key: 145657848
• Report Number: MW5086720
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 59676082001
• UDI-Public: 59676082001
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• 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: 0