MAUDE Adverse Event Report: ZIMMER/SEIKAGAKU CORPORATION, TAKAHAGI PLANT GELONE; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/28/2020

Event Type  Injury  

Event Description

Patient reports surgery for cancer ongoing arx did not fill prev rx.(b)(6).

• Brand Name: GELONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ZIMMER/SEIKAGAKU CORPORATION, TAKAHAGI PLANT
• MDR Report Key: 11108098
• MDR Text Key: 225148561
• Report Number: MW5098629
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR