MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC PFS 8/ML (3X2ML); ACID, HYALURONIC, INTRAARTICULAR

Lot Number CRSP012Z

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 01/17/2023

Event Type  Injury  

Event Description

The patient indicated on the portal order that she "had a gallstone removed outpatient surgery (b)(6) 2023; i had my gallbladder removed outpatient surgery (b)(6) 2023 tripped and fell and fractured my humerus bone near my right shoulder in 2 places.Bone is mending and i am currently going outpatient therapy twice weekly.".

• Brand Name: SYNVISC PFS 8/ML (3X2ML)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 17031582
• MDR Text Key: 316318604
• Report Number: MW5117989
• 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: Patient
• Type of Report: Initial
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: CRSP012Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female