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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC (3X2ML PREFILLED SYR) ACID, HYALURONIC, INTRAARTICULAR

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GENZYME CORPORATION SYNVISC (3X2ML PREFILLED SYR) ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Lot Number 9RST023C
Device Problem Device Fell (4014)
Patient Problem Insufficient Information (4580)
Event Date 07/14/2021
Event Type  malfunction  
Event Description
Md office to report that when the md staff opened the medication (today (b)(6) 2021), the plunger fell out. The patient has not yet started the course of therapy, so there has not yet been any missed doses, no other information provided. Reported to (b)(6) by health professional.
 
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Brand NameSYNVISC (3X2ML PREFILLED SYR)
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORPORATION
MDR Report Key12384748
MDR Text Key268975511
Report NumberMW5103560
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 07/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number9RST023C
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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