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

Catalog Number 00111100100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Itching Sensation (1943)

Event Date 07/16/2019

Event Type  Injury  

Event Description

It was reported that thirty minutes after a hyaluronate sodium (gel-one) injection was used in patient's right knee, the patient went to a smokehouse and turned white, then felt his throat closing and itching throughout his body (especially over the face and neck).The patient was then admitted and given diphenhydramine, methylprednisolone and ranitidine.Patient's condition eventually improved.No additional patient consequences are known at this time.

• 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: 8955876
• MDR Text Key: 156300242
• Report Number: 0001822565-2019-03552
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/03/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/15/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other