MAUDE Adverse Event Report: SEIKAGAKU CORPORATION SUPARTZ FX; ACID, HYALURONIC, INTRAARTICULAR

Model Number 89130-4444-01

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

This case was reported from a consumer to fda directly.No additional information are available.

Event Description

2019-unk: a patient received 1st injection of supartz fx to the left knee for knee / joint pain, stiffness, fluid retention.2019-unk: the patient received 2nd injection to the bilateral knees next week.2019-unk: the patient received 3rd injection to the right knee.(b)(6) 2019: the patient felt that both knees were extremely heavy, and felt as if they were splitting in half when the patient tried to get out of bed or rise from sitting position.Both knees were extremely swollen.The patient could barely walk without a cane or assistance.2019-unk: a doctor prescribed steroids for a week.2019-unk: the patient started seeing chiropractor for treatment.Other treatment also included massage therapy.2019-unk: the patient recovered and was able to get back to gym for exercise.

• Brand Name: SUPARTZ FX
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION; marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0 005; JA 100-0005
• Manufacturer (Section G): SEIKAGAKU CORPORATION - TAKAHAGI PLANT; 258-5, aza-matsukubo; oaza-akahama; takahagi-shi, ibaraki 318-0 001; JA 318-0001
• Manufacturer Contact: marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0-005
• MDR Report Key: 9646477
• MDR Text Key: 190515123
• Report Number: 9612392-2020-00001
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89130-4444-01
• Device Catalogue Number: 7156-4444
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other