MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC ONE PFS 8MG/ML; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 09/03/2020

Event Type  malfunction  

Event Description

(b)(6) med asst from the dr's office called to say the doctor found a foreign object floating around in the synvisc one pfs 8mg/ml.The doctor's office said it looks like fiber floating around in the liquid.I have provided the manufacturer's telephone number.

• Brand Name: SYNVISC ONE PFS 8MG/ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10501581
• MDR Text Key: 206142596
• Report Number: MW5096461
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009003
• UDI-Public: 58468009003
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR