MAUDE Adverse Event Report: SEIKAGAKU CORP., TAKAHAGI PLANT GEL-ONE; ACID, HYALURONIC INTRAARTICULAR

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 02/19/1959

Event Type  Injury  

Event Description

Patient stated that she had a knee surgery.Mfr: zimmer biomet.

• Brand Name: GEL-ONE
• Type of Device: ACID, HYALURONIC INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORP., TAKAHAGI PLANT
• MDR Report Key: 7650311
• MDR Text Key: 112909741
• Report Number: MW5078158
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR