MAUDE Adverse Event Report: ZIMMER, INC. GEL ONE SYRINGE; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Spontaneous: patient advised that she had brought the gel-one into the doctor¿s office for the injection.She reported that as soon as the doctor started the injection, the medications started to leak out of the syringe and barely any was injected into the knee before the doctor has to stop due to sterility concerns.Patient did not have the lot or expiration date available as everything was being kept at the doctor¿s office.No additional side effects were reported as a result of this.Reported to (b)(6) by: patient/caregiver.

• Brand Name: GEL ONE SYRINGE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ZIMMER, INC.
• MDR Report Key: 9829045
• MDR Text Key: 184155308
• Report Number: MW5093729
• 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: 03/02/2020

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
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2020
• Patient Sequence Number: 1