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

Model Number 89130-4444-01

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Type  Injury  

Manufacturer Narrative

This is a definitive report.This was reported from the patient's relative and further information was not available.It was considered that the event could be possibly related to the injection but also related to the patient's condition because the event occurred 1 week after the injection.Seikagaku corporation is also submitting this report on behalf of (b)(4) as the importer with authorization by the exemption number (b)(4).

Event Description

(b)(6) 2017 - a male patient received 5 injections of spartz weekly for osteoarthritis.(b)(6) 2017- he developed severe hives on his legs 1 week after the last injection.They were so bad, he ended up in the hospital for several days.They were trying to find a cause and that is the only thing that was done to his body.(b)(6) 2017 - he was out of the hospital but the hives came back again.

• Brand Name: SUPARTZ FX
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION; 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: 7011785
• MDR Text Key: 91440695
• Report Number: 9612392-2017-00011
• 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: 10/13/2017,10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/12/2017
• Date Report to Manufacturer: 10/13/2017
• Initial Date Manufacturer Received: 10/16/2017
• Initial Date FDA Received: 11/08/2017
• 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): Hospitalization