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

Catalog Number 00111100100

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033); Urticaria (2278); Reaction (2414)

Event Date 10/20/2020

Event Type  Injury  

Event Description

It was reported that the patient received a gel-one injection in her left knee and developed itchy skin, hives and a red bumpy rash all over the body approximately 3 to 4 days after injection.She has been on numerous rounds of steroids, antihistamines and creams and has not had any relief on symptoms.

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: 11109552
• MDR Text Key: 224850621
• Report Number: 0001822565-2021-00018
• 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
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

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 Expiration Date: 09/08/2022
• Device Catalogue Number: 00111100100
• Device Lot Number: 0020G20G
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention