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U.S. Department of Health and Human Services

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

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BIOVENTUS LLC GELSYN-3 PFS ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
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.
 
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Brand NameGELSYN-3 PFS
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
BIOVENTUS LLC
MDR Report Key10179969
MDR Text Key196211033
Report NumberMW5095139
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received06/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number1909023
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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