MAUDE Adverse Event Report: SEIKAGAKU CORP. GEL-ONE; ACID, HYALURONIC, INTRAARTICULAR

Lot Number 0017Z14G

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

The luer lock tip dislodged from the body of the syringe at the end of adminstration by an experienced nurse practitioner (lot #0017z14g).Patient received full amount.Strength: 10 mg/ml - milligrams per millilitres.Dose or amount: 30 mg milligrams.Route: intra-articular.Therapy start date: (b)(6) 2018.Therapy end date: (b)(6) 2018.

• Brand Name: GEL-ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORP.
• MDR Report Key: 7600523
• MDR Text Key: 111199655
• Report Number: MW5077833
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• 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: 06/12/2018

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
• Device Expiration Date: 01/31/2019
• Device Lot Number: 0017Z14G
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1