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

Lot Number 4L1B26

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 08/23/2021

Event Type  Injury  

Manufacturer Narrative

This is a definitive report.Four cases were reported from a physician.The physician commented that the cause might be not only artz dispo but also the other factors such as injection procedures.No further information will be expected because the physician refuses to cooperate with us.480 syringes were delivered to the reported clinic for 3 months.Company comment: according to the result of investigations, 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.4l1b26.Manufacturer's causality assessment is determined as "not related".

Event Description

(b)(6) 2021: a (b)(6) female patient received an injection of artz dispo for gonarthrosis.(b)(6) 2021: she was diagnosed with septic arthritis because staphylococcus aureus was detected.

• 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, 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: 12587442
• MDR Text Key: 276346282
• Report Number: 9612392-2021-00008
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 4L1B26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2021
• 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
• Patient Age: 67 YR