MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

I wanted to report the below manufacturer error to (b)(6) and thought sending the pies via email would be best.The 30 qr barcode on the synvisc (hyaluronate) box is scanning as kynamro (mipomersen).It appears that the gtin# (b)(4) incorrectly includes the ndc of the kynamro ((b)(4)).Genzyme has been notified but we haven't heard back yet.Type: wrong drug preparation.Contributing factors: unauthorized substitution / wrong brand mfr / labeler.Special code: mfr corrective action.Severity: circumstances or events have capacity to cause error.(b)(6).

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 12377063
• MDR Text Key: 270323160
• Report Number: MW5103519
• Device Sequence Number: 1
• Product Code: MOZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1