MAUDE Adverse Event Report: SEIKAGAKU CORPORATION GEL-ONE X-LINKED HYALUR 3ML ACID, HYALURONIC, INTRAARTICULAR

Catalog Number 00111100100

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Swelling (2091); Cramp(s) (2193); Reaction (2414); Alteration In Body Temperature (2682); No Code Available (3191)

Event Date 08/01/2019

Event Type  Injury  

Event Description

It was reported that the patient had pain, swelling, cramps in legs, cold feet, hot legs, electrical shock feeling post gel-one injection on left knee. No additional patient consequences were reported.

• Brand Name: GEL-ONE X-LINKED HYALUR 3ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION; 6-1, marunouchi; 1-chrome chiyoda-ku, tokyo 100-0 005; JA 100-0005
• MDR Report Key: 9083555
• MDR Text Key: 162448524
• Report Number: 0001822565-2019-04036
• 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: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 00111100100
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/11/2019
• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 09/18/2019 Patient Sequence Number: 1