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 Problem Urinary Tract Infection (2120)

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

This is a definitive report.This was reported from a staff of physician's clinic and the physician confirmed the event.According to the physician's staff, they were wondering if the injection was possibly contaminated, because they were unsure of why he got so ill.Injection physician stated it was very unlikely that the injection was contaminated or that it caused his infections.According to the result 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 no.4x7c29.Furthermore, no infectious event has been reported from other facilities in the us except for this case, the urinary tract infection was therefore not related to product quality.It was considered that the causal relationship was "not related" because community-acquired infection could be suspected.(b)(4).

Event Description

On (b)(6) 2017 - a male patient received 1st injection of supartz fx to the knee for osteoarthritis.On (b)(6) 2017 - he received 2nd injection of supartz fx.On (b)(6) 2017 - he received 3rd injection of supartz fx.On (b)(6) 2017 - he received 4th injection of supartz fx.He was vomiting at night.On (b)(6) 2017 - he ended up in the er with a fever.He was diagnosed with e.Coli and an urinary tract infection.On (b)(6) 2017 - he was taking medications that were prescribed.He was feeling a little bit better.

• Brand Name: SUPARTZ FX
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION; pharmacovigilance dept.; 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-aka; 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: 7182183
• MDR Text Key: 96972273
• Report Number: 9612392-2018-00001
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Public: +$$32008314X7C29RF
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2017,12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 89130-4444-01
• Device Catalogue Number: 7156-4444
• Device Lot Number: 4X7C29
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/12/2017
• Device Age: 8 MO
• Date Report to Manufacturer: 12/13/2017
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2017
• 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): Hospitalization