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

Device Problem Shipping Damage or Problem (1570)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Per clarification response from md office, the patient has quantity of one syringe for the synvisc one injection for a onetime dose injected into the hip for hip pain.Medication has not shipped from (b)(6).No further information provided.Reported to (b)(6) by: health professional.

• Brand Name: SYNVISC ONE PFS
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 11055743
• MDR Text Key: 223455559
• Report Number: MW5098480
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 12/16/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2020
• Patient Sequence Number: 1