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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number ARSL019B
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Arthralgia (2355)
Event Date 01/01/2021
Event Type  Injury  
Event Description
Joint was aspirated [joint aspiration]. Feeling increasing pain [arthralgia aggravated]. Case narrative: initial information received on (b)(6) 2021 regarding an unsolicited valid serious case received from a physician from (b)(6). This case is linked to case (b)(4) (same patient). This case involves male patient who was feeling increasing pain and joint was aspirated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received treatment with hylan g-f 20, sodium hyaluronate injection (frequency, dose, route and indication: unknown) (lot - arsl019b with unknown expiration date) in left knee. On an unknown date of (b)(6) 2021, after unknown latency patient was feeling increasing pain in knee (arthralgia). On an unknown date in 2021, after unknown latency the left knee joint was aspirated (aspiration joint). Analysis of left knee revealed no bacteria. Both the events were assessed as serious with seriousness criteria of intervention required. Action taken: not applicable for both events. Corrective treatment: not reported for both events. Outcome: unknown for both events.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key12622455
MDR Text Key277613551
Report Number2246315-2021-00164
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberARSL019B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/13/2021 Patient Sequence Number: 1
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