MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC ONE 48 MG; ACID, HYALURONIC, INTRAARTICULAR

Lot Number 6RSL050

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

Patient Problems Bronchitis (1752); Laceration(s) (1946)

Event Type  Injury  

Event Description

Pt reported that she is currently in the hospital for chronic bronchitis and a lacerated bladder.Onset date reported as within the last 30 days.

• Brand Name: SYNVISC ONE 48 MG
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10851977
• MDR Text Key: 216894293
• Report Number: MW5097923
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009003
• UDI-Public: 58468-0090-03
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 6RSL050
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization