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

Model Number 89130-4444-01

Device Problem Insufficient Information (3190)

Patient Problem Anaphylactic Shock (1703)

Event Type  Injury  

Manufacturer Narrative

This case is received by bioventus on (b)(6), 2022 and it was forwarded to manufacturer on december 8.Follow ups for additional information are now in progress in bioventus.

Event Description

Unknown - a patient went into anaphylactic shock following a supartz fx injection.

Manufacturer Narrative

This case was received by bioventus on december 5, 2022 and it was forwarded to the manufacturer on december 8.This case was filed to the fda on december 27 from the manufacturer and also filed on december 30 from bioventus as 3009595577-2022-00006.No update was provided from the follow up.Dates of the follow up attempts were the followings; dec 7th - email follow up sent to the rep, dec 19th - fax sent to the physician's office, dec 19th - phone call place to sales rep, dec 20th - email sent to follow up with physician, dec 30th - phone call placed to the physician's office.

• 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: 16051939
• MDR Text Key: 306176476
• Report Number: 9612392-2022-00010
• 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,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2023
• 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): Life Threatening; Other