MAUDE Adverse Event Report: SEIKAGAKU CORP, TAKAHAGI PLANT VISCO-3 25 MG/2.5 ML PFS (3/BOX) INJ; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2018

Event Type  Injury  

Event Description

Only 1 syringe of the visco 3 was sent to (b)(6) office instead of 3 syringes - no missed doses, 2 syringes is reshipped to (b)(6) office.Dates of use: (b)(6) /2018 to present.

• Brand Name: VISCO-3 25 MG/2.5 ML PFS (3/BOX) INJ
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORP, TAKAHAGI PLANT; 101 constitution ave nw; ste 900; washington DC 20001
• MDR Report Key: 8019306
• MDR Text Key: 125708944
• Report Number: MW5080921
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 87541030131
• UDI-Public: 87541030131
• Combination Product (y/n): N
• 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: 10/22/2018

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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR