MAUDE Adverse Event Report: ZIMMER / SEIKAGAKU CORP. GEL ONE SYRINGE; ACID, HYALURONIC, INTRAARTICULAR

Lot Number 0018H03G

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2018

Event Type  malfunction  

Event Description

Spontaneous call received from md office reporting defective device.When md twisted needle onto syringe, gel one medication spilled out; patient did not experience any adverse event.No additional information available.Syringe is available for retrieval.Reported to (b)(6) by: health professional; dose or amount: 30mg; frequency: once; route: intra-articular; dates of use: from unknown to unknown; diagnosis or reason for use: osteoarthritis, left knee.

• Brand Name: GEL ONE SYRINGE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ZIMMER / SEIKAGAKU CORP.
• MDR Report Key: 8227683
• MDR Text Key: 132567153
• Report Number: MW5082911
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/14/2019
• Device Lot Number: 0018H03G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 43 YR