MAUDE Adverse Event Report: IBSA FARMACEUTICI ITALIA SRL GELSYN KNEE INJECTION ; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Pain (1994); Ambulation Difficulties (2544)

Event Date 12/14/2019

Event Type  Injury  

Event Description

Caller stated she received the injection in both knees 16.8 mg, 2ml, on (b)(6) 2019.Caller experienced worsened pain in both knees and itching in her left leg.The pain has caused difficulty ambulating.

• Brand Name: GELSYN KNEE INJECTION
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): IBSA FARMACEUTICI ITALIA SRL
• MDR Report Key: 9596341
• MDR Text Key: 175729267
• Report Number: MW5092307
• Device Sequence Number: 2
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/15/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR