MAUDE Adverse Event Report: BIOVENTUS LLC GELSYN-3 PFS; ACID, HYALURONIC, INTRAARTICULAR

Lot Number 1909023

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

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

Event Date 06/08/2020

Event Type  malfunction  

Event Description

Spontaneous contact from (b)(6) at md office: prescriber was injecting one syringe into knee on (b)(6) 2020 and the needle detached from the syringe and the medication poured out.Pt did not miss a dose and no adverse effect was reported; at the time of report the device was available for return.No other information provided.Dosing/frequency information: inject one syringe intra-articularly to bilateral knees once weekly for 3 weeks at the physician's office.Reported to (b)(6) by: health professional.Dates of use: from (b)(6) 2020 to current.

• Brand Name: GELSYN-3 PFS
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 10179969
• MDR Text Key: 196211033
• Report Number: MW5095139
• 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: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2022
• Device Lot Number: 1909023
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 59 YR