MAUDE Adverse Event Report: SEIKAGAKU CORPORATION GEL-ONE X-LINKED HYALUR 3ML; BIOLOGICS

Catalog Number 00111100100

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Cyst(s) (1800)

Event Type  Injury  

Event Description

It was reported that the patient received a gel one injection at an unknown date.Subsequently, the patient had a baker's cyst after the injection that filled up with fluid.The patient is feeling better now after the fluid was drained out by the doctor.No additional patient consequences are reported.

• Brand Name: GEL-ONE X-LINKED HYALUR 3ML
• Type of Device: BIOLOGICS
• Manufacturer (Section D): SEIKAGAKU CORPORATION; 6-1, marunouchi; 1-chrome chiyoda-ku, tokyo 100-0 005; JA 100-0005
• MDR Report Key: 11165049
• MDR Text Key: 226645131
• Report Number: 0001822565-2021-00147
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00111100100
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention