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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOVENTUS LLC SUPARTZ FX PFS ACID, HYALURONIC, INTRAARTICULAR

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BIOVENTUS LLC SUPARTZ FX PFS ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Defective Component (2292)
Patient Problem Injury (2348)
Event Type  malfunction  
Event Description
Spontaneous call from patient reported that medication was damaged when the doctor opened it. The doctor stated that the syringe id was not on correctly. Unknown if patient experience an adverse event due to the defective product. Unknown if the patient has the product on hand. Spontaneous call. No additional information. Frequency: once weekly for 2 weeks. Reported to (b)(6) by: patient/caregiver.
 
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Brand NameSUPARTZ FX PFS
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
BIOVENTUS LLC
MDR Report Key9495866
MDR Text Key172409273
Report NumberMW5091756
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 12/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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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