MAUDE Adverse Event Report: SEIKAGAKU CORPORATION, TAKAHAGI PLANT GEL ONE 30/3 MG/ML - MILLLIGRAMS PER MILLILITRES; ACID, HYALURONIC, INTRAARTICULAR

Lot Number 0020D24G

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2020

Event Type  Injury  

Event Description

Member's wife has reported the member is in hospice.Event ongoing.

• Brand Name: GEL ONE 30/3 MG/ML - MILLLIGRAMS PER MILLILITRES
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION, TAKAHAGI PLANT
• MDR Report Key: 10627891
• MDR Text Key: 209978389
• Report Number: MW5097048
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 87541030091
• UDI-Public: 87541-0300-91
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/02/2022
• Device Lot Number: 0020D24G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 93 YR