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

Model Number 00-1111-001-00

Device Problem Insufficient Information (3190)

Patient Problem Spinal Column Injury (2081)

Event Type  Injury  

Manufacturer Narrative

This concerned lot number was not available, however we regard it as 0019x22g or 0019x23g from the reported expiration date.Those lot number were delivered in the u.S.In december 2019.We attempt to contact the reporter for the details through our us partner.

Event Description

On (b)(6): a (b)(6) year-old female patient received gel-one injection into the knees for osteoarthritis.The reported pharmacy shipped gel-one on 2020-04-06.On (b)(6) 2020: the patient had 2 emergency back surgeries this month.

Manufacturer Narrative

This is a definitive report.H6 and h10 were updated.According to our us partner on (b)(6) 2020, no additional information was available in contact attempts on (b)(6).This concerned lot number was not available, however we regard it as 0019x22g or 0019x23g from the reported expiration date.Those lot number were delivered in the u.S.In (b)(6) 2019.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# both 0019x22g and 0019x23g.We selected the code of 4316 (appropriate term/code not available) for h.6 manufacturer evaluation conclusion code, because the reported adverse event was not listed in the package insert and concerned lot number was not available.

Event Description

2020-unk: a (b)(6) female patient received gel-one injection into the knees for osteoarthritis.The reported pharmacy shipped gel-one on (b)(6) 2020.(b)(6) 2020 unk: the patient had 2 emergency back surgeries this month.

• 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
• MDR Report Key: 10111342
• MDR Text Key: 195533833
• Report Number: 9612392-2020-00007
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P080020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Model Number: 00-1111-001-00
• Device Catalogue Number: 00-1111-001-00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR