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

Model Number 89130-4444-01

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

Patient Problems Hot Flashes/Flushes (2153); Reaction, Injection Site (2442); No Code Available (3191)

Event Date 08/22/2019

Event Type  Injury  

Manufacturer Narrative

This is a definitive report.No further information can be obtained.This case report was received on sep 23, 2019 from the fda as mw5089675 dated sep 16, 2019.It was stated the affected lot number was 4x7207 in the actual letter.Review of the manufacturing records about 4x7z07 and 4x7z01 instead of 4x7207 were performed because there is no corresponding number.According to the results of investigation, there were no deviations or out-of-specifications found in the manufacturing process, the in-process testing, the release testing, and the environmental monitoring for lot# 4x7z07 and 4x7z01.

Event Description

Unk: a female patient received supartz fx injection.(b)(6) 2019: she experienced warmth at injection site, flushing, waves of heat.Her pupils were dilated.

• 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, 100-0 005; JA 100-0005
• Manufacturer (Section G): SEIKAGAKU CORPORATION - TAKAHAGI PLANT; 258-5, aza-matsukubo; oaza-akahama; takahagi-shi, 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: 9207296
• MDR Text Key: 165960810
• Report Number: 9612392-2019-00015
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Public: +$$32105314X7Z07RW
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 89130-4444-01
• Device Catalogue Number: 7156-4444
• Device Lot Number: 4X7Z07
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2017
• 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