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

Lot Number 50208

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Swelling (2091); Skin Inflammation (2443)

Event Date 08/21/2003

Event Type  Injury  

Event Description

About 12 hours after injection, he had swelling, warmth, and severe pain in his knees to the point that he was unable to ambulate.The severe pain lasted approximately 1.5 days, but the swelling remained a week later.This happened with the first two injections after having had several rounds of three injections weekly without any adverse reaction; biomatrix / wyeth.

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10829253
• MDR Text Key: 216191760
• Report Number: MW5097795
• 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: Physician
• Type of Report: Initial
• Report Date: 08/29/2003

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/01/2005
• Device Lot Number: 50208
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 108