MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC SODIUM HYALURONATE (HYLAN G-F20); ACID, HYALURONIC, INTRAARTICULAR

Device Problem Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  No Answer Provided  

Event Description

While developing pre-authorization criteria for viscosupplementation with synvisc and, coincidentally, new criteria for the rsv monoclonal antibody, synagis, the report was struck by the similarity of the names.The sound alike drug names create a potential for error.Was the medication administered to or used by the patient? no.What type of staff or health care practitioner made the initial error? n/a.Who discovered the errors? n/a.Where did the error occur (e.G.Hospital, outpatient or retail pharmacy, nursing home, patient's home)? n/a.(b)(6) (b)(4).

• Brand Name: SYNVISC SODIUM HYALURONATE (HYLAN G-F20)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10816439
• MDR Text Key: 216195878
• Report Number: MW5097757
• 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: 10/12/1998

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2020
• Patient Sequence Number: 1