MAUDE Adverse Event Report: SEIKAGAKU CORPORATION GEL-ONE; ACID, HYALURONIC, INTRAARTICULAR

Model Number 00-1111-001-00

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

This is a definitive report.This case is received by seikagaku corporation on (b)(6) 2020 from the fda as mw5094339 dated (b)(6) 2020.No further information will be expected, since no contact information is available.The reported lot number was 0018j4g, but it was wrong.Based on the reported expiration date of 2019-11-25, we assume it must be of 0018j14g.According to the result of investigation for 0018j14g, there were no deviations or out-of-specifications, that could relate to the reported adverse event, found in the manufacturing process, the in-process testing, the release testing, and the environmental monitoring.Although the injection date of gel-one was not specified, it is reasonably considered to be prior to the expiration date; 2019-11-25.Since the event occurred in 2020, it is highly unlikely that the event was related to the product.

Event Description

Unk - a female patient received gel-one injection into the knee for osteoarthritis.The expiration date of the product was 2019-11-25.On (b)(6) 2020 - the patient was hospitalized for surgery after fracturing her humerus on 2020-[masked].

• Brand Name: GEL-ONE
• 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: marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0-005
• MDR Report Key: 10102910
• MDR Text Key: 195117442
• Report Number: 9612392-2020-00006
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 00087541300912
• UDI-Public: (01)00087541300912(17)191125(10)0018J14G(442)392
• Combination Product (y/n): N
• PMA/PMN Number: P080020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2019
• Device Model Number: 00-1111-001-00
• Device Catalogue Number: 00-1111-001-00
• Device Lot Number: 0018J14G
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2018
• 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