MAUDE Adverse Event Report: GENZYME CORPORATION HYLAN G-F 20 (HYLAN G-F20 16MG/2ML INJ,SYRINGE,2ML); ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Reaction (2414); Swelling/ Edema (4577)

Event Date 09/15/2018

Event Type  Injury  

Event Description

Patient had pseudoseptic reaction where he was instructed to rest the knees as much as possible and had severe difficulty walking for weeks.Symptom: swelling, pain, effusion, pseudoseptic reaction in knee suspect drug # 1 dosing: one-time injection in both knees treatment drugs used.

• Brand Name: HYLAN G-F 20 (HYLAN G-F20 16MG/2ML INJ,SYRINGE,2ML)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 11139053
• MDR Text Key: 226275109
• Report Number: MW5098724
• 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: 10/21/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 57 YR
• Patient Weight: 71