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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC MOZ Back to Search Results
Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
Bedridden, inflamed ([inflammation nos), painful reaction (pain). Case narrative: initial information received on (b)(6) 2021 from (b)(6) regarding an unsolicited valid social media serious case received from a consumer/non-hcp. This case involves adult female patient who experienced bedridden, inflamed and painful reaction while being treated with hylan g-f 20, sodium hyaluronate (synvisc). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection, (strength, batch number, route, frequency: unknown). Information for batch number requested. On the unknown date, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient had painful reaction (pain) due to synvisc infiltration. Patient was inflamed (inflammation) and was bedridden (disability) for a nearly a week. Action taken with hylan g-f 20, sodium hyaluronate (synvisc) was unknown. It was not reported if the patient received a corrective treatment for the events (inflamed, bedridden, painful reaction). Outcome: recovered for bedridden; unknown for both the events.
 
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Brand NameSYNVISC
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 Key13098006
MDR Text Key288091185
Report Number2246315-2021-00184
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 Consumer,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
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: 12/28/2021 Patient Sequence Number: 1
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