MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Pain (1994)

Event Date 08/08/2018

Event Type  Injury  

Event Description

Spoke to (b)(6), a clinical coord from dr (b)(6)'s office.They state the pt is saying that the original synvisc inject back in (b)(6) was ineffective.They are experiencing knee pain in both knees.Inj 8mg/ml (3x2ml), from (b)(6) 2018 to (b)(6) 2018.Is the product compounded? no; is the product over-the-counter? no.

• Brand Name: SYNVISC
• Type of Device: SYNVISC
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 7780291
• MDR Text Key: 117192505
• Report Number: MW5079102
• Device Sequence Number: 1
• Product Code: MOZ
• 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: 08/08/2018

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: 08/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR