MAUDE Adverse Event Report: GENZYME SYNVISC ONE INJ 8MG/ML ; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 07/19/2018

Event Type  Injury  

Event Description

Medical dr office called in and stated that their pt had a possible "allergic" reaction to synvisc.They ordered the medication in (b)(6) but pt may have declined to take it.They are not sure.We showed that the prescription was not shipped.Dates of use: (b)(6) 2018 - (b)(6) 2018.

• Brand Name: SYNVISC ONE INJ 8MG/ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME
• MDR Report Key: 7880718
• MDR Text Key: 120636013
• Report Number: MW5079838
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009003
• UDI-Public: 58468009003
• Combination Product (y/n): N
• 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: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR