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

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

Patient Problems High Blood Pressure/ Hypertension (1908); Itching Sensation (1943); Rash (2033)

Event Date 06/02/1999

Event Type  No Answer Provided  

Event Description

"on (b)(6) 1999 injection of right knee synvisc.Two days after injection itching, rash in upper body.Hypertension (204/102) at (b)(6) hospital?".

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10836827
• MDR Text Key: 216411586
• Report Number: MW5097845
• Device Sequence Number: 1
• Product Code: MOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/1999

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?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR