MAUDE Adverse Event Report: SEIKAGAKU CORPORATION/ZIMMER BIOMET GEL-ONE SYRINGE; ACID, HYALURONIC, INTRAARTICULAR

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2023

Event Type  malfunction  

Event Description

Spontaneous.(b)(6) cma at md office reported that during injection appointment, md stated medication squirted out of the other end of syringe on (b)(6) 2023.Other syringe on the right knee was administered fine.Need to send out replacement for left knee.Patient missing injection for left knee.No adverse events reported.Defective device is not available for return.No further information.Reported to (b)(6) by: health professional.

• Brand Name: GEL-ONE SYRINGE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION/ZIMMER BIOMET
• MDR Report Key: 18545104
• MDR Text Key: 333390241
• Report Number: MW5150555
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2024
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male