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

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

Event Date 04/15/2024

Event Type  malfunction  

Event Description

Spoke with (b)(6), md who reported he had issue with both gel one syringes, tried to inject on (b)(6) 2024, when injecting 1st dose, lot of resistance and medication would not come out the syringe popped off of the device and unscrewed from needle and liquid in syringe spilled everywhere; same thing happened with second syringe.Md tried to use another needle (18g) thinking that might be the issue - same issue - medication would not come out.Cannot try again due to sterility.Md states he has injected other items like steroids with this pt with no issues.He has also never had any issue with gel one syringe before as well.Possible defective device.Lot number dd23j27g and expiration date 11/19/2025 for both syringes.Patient missed dose.No adverse event reported.Unknown if patient still has defective device on hand for return.No further information provided.Indication: bilateral primary osteoarthritis of knee.Reported to (b)(6) by health professional.Ref report: mw5153904.

• Brand Name: GEL ONE SYRINGE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION, TAKAHAGI PLANT
• MDR Report Key: 19125980
• MDR Text Key: 340480441
• Report Number: MW5153903
• 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: 04/15/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2024
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female