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

Device Problems Material Separation (1562); Failure to Deliver (2338); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

Route of administration: intra-articularly to the left knee; spontaneous call from (b)(6)licensed practical nurse from md office calling to report malfunctioning of gel-one syringe, she said when doing the injection the needle came off and got separated and the medication didn't get injected.No adverse event reported.Missed dose reported.Unk if md office has defective device on hand.No further info available.Reported to (b)(4) by health professional.

• Brand Name: GEL-ONE SYRINGE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ZIMMER BIOMET / SEIKAGAKU CORPORATION, TAKAHAGI PLANT
• MDR Report Key: 10785600
• MDR Text Key: 214798615
• Report Number: MW5097634
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1