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

Model Number 89130-4444-01

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 03/03/2022

Event Type  Injury  

Event Description

A female patient received the entire set of supartz fx injections into the knee for osteoarthritis.(b)(6) 2022- the last injection was performed.(b)(6) 2022 - the patient noticed severe back pain that started in the right side of her low back, thigh, knee, and shin.She immediately started icing the affected areas and taking tylenol and ketorolac tablets on top of her normal pain meds which include oxycontin, oxycodone, lyrica, diclofenac, and flexeril.None of these things seemed to help.She had been bedridden since.(b)(6) 2022 - the patient called her doctor and started steroids.After two days of steroids, she was able to function somewhat better, but later that day the pain began again and is back with vengeance.She was not able to walk to the bathroom or sit on the toilet for longer than about 30 seconds.The pain started surging down her leg and it throbs and was stabbing.Like someone was stabbing her repeatedly in her low back, all the way down her leg.She had been in tears and had not been able to function to do the simplest activities.She was miserable and wanted to file a lawsuit at this point.This type of side effects should be listed on the medication and should be required to have the person getting this injection to know that there is a possibility that this type of thing can happen.(the patient report this event to fda on 2022-03-09.).

Manufacturer Narrative

No detailed information is available through our us partner even though several attempts were made to contact the patient.This case is received by seikagaku corporation on april 4, 2022 from the fda as mw5108029 dated march 28, 2022.

• 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: pharmacovigilance dept ; marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0-005 ; JA 100-0005
• MDR Report Key: 14167096
• MDR Text Key: 289759203
• Report Number: 9612392-2022-00001
• 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: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 89130-4444-01
• Device Catalogue Number: 7156-4444
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2022
• 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
• Patient Sex: Female