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

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

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 08/03/1998

Event Type  Injury  

Event Description

On 7/22 - patient received 1st dose of synvisc in left knee.On 7/29 - patient received 2nd dose of synvisc.On 8/3 - patient called complaining of hives oj buttocks, face, behind ears and on thighs, and difficulty breathing.Pt was rxd with benadryl 25 mg 1-2 capsules.Q4-6h prn.Pt also had epi pen on hand if having more difficulty with breathing.On 8/5 - patient received 3rd dose of synvisc.On 8/10 - pt began having chills, welts and hives all over body, anxiety.She denies swelling of knee, red or hot to touch.She was rxd with allegra q12h with some relief.Assessment: urticaria secondary to synvisc injections.

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10816420
• MDR Text Key: 216185725
• Report Number: MW5097754
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 05/03/2000
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR