MAUDE Adverse Event Report: SEIKAGAKU CORPORATION ARTZ DISPO; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problem Viral Infection (2248)

Event Type  Injury  

Manufacturer Narrative

This is a definitive report.This case was reported from a literature.According to the physician, repeated hyaluronic acid injections for osteoarthritis treatment were suspected to be the cause of hcv transmission.The product name of sodium hyaluronic injection was not identified in the report.Even if the product was artz/artz dispo, all of our product batches were prepared from raw material that inactivated and removed virus, with process that had performances of inactivating virus.It was therefore considered that the product quality was not related to acute (b)(6) virus transmission.No adverse event of acute (b)(6) transmission has been reported except for this case over 30 years.Manufacturer's causality assessment is determined as "not related".Note that no additional information would be available, since the reporter refused to cooperate investigations completely and we didn't have any other clues.

Event Description

Unk - a (b)(6) year-old male received 18 hyaluronic acid injections for right knee osteoarthritis over the last 6 months at another local clinic.Unk - he had acute (b)(6) monoinfection on the basis of (b)(6) seroconversion with yellow discoloration of the sclera and epigastrium for 7 and 4 days, respectively, and liver dysfunction.A transjugular liver biopsy confirmed submassive hepatic necrosis.Unk - five days after admission, no flapping tremor was observed.Considering that rapid (b)(6) clearance and temporary suppression of the immune response would prevent acute liver failure (alf), he received oral ledipasvir (ldv) 90 mg and sofosbuvir (sof) 400 mg for 12 weeks and intravenously injected methylprednisolone 1 g for 3 days.Unk - there were no adverse events associated with ldv/sof.He was discharged 73 days after admission.A sustained virological response was achieved at 12 and 24 weeks after treatment.

• Brand Name: ARTZ DISPO
• 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: marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0-005
• MDR Report Key: 9523194
• MDR Text Key: 189048102
• Report Number: 9612392-2019-00021
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P980044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/27/2019
• 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; Other
• Patient Age: 72 YR