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

Catalog Number 00111100100

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Anaphylactic Shock (1703); Urticaria (2278)

Event Date 09/12/2019

Event Type  Injury  

Event Description

It was reported that post gel one injection in both knees, the patient went to emergency for apparent anaphylactic reactions such as hives and breathing difficulty.The patient was treated with steroids and discharged.No additional patient consequences were reported.

Event Description

No additional event information is available at the time of this report.

• 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
• MDR Report Key: 9179607
• MDR Text Key: 164129324
• Report Number: 0001822565-2019-04384
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/17/2019,10/21/2019

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: Health Professional
• Device Catalogue Number: 00111100100
• Device Lot Number: 0019F07G
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/17/2019
• Distributor Facility Aware Date: 10/07/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 10/21/2019
• Supplement Dates FDA Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other