MAUDE Adverse Event Report: SEIKAGAKU CORP. GEL-ONE INJ 30MG/3ML; ACIDHYALURONIC, INTRAARTICULAR

Device Problems Product Quality Problem (1506); Improper Flow or Infusion (2954)

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

Event Date 06/23/2017

Event Type  Injury  

Event Description

On (b)(6)2017 - order (b)(4) gel-one, nurse went to go perform injection of gel-one and medication came out of side of needle and nurse was unable to complete injection.

• Brand Name: GEL-ONE INJ 30MG/3ML
• Type of Device: ACIDHYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORP.
• MDR Report Key: 6669497
• MDR Text Key: 78587137
• Report Number: MW5070639
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 87541030091
• UDI-Public: 87541030091
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• 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: 54 YR