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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthralgia (2355); Swelling/ Edema (4577)
Event Type  Injury  
Event Description
Knee is very swollen and painful [injection site joint swelling]. Knee is very swollen and painful [injection site joint pain] body aches [general body pain]. Case narrative: initial information received on (b)(6) 2021 from (b)(6) regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves an unknown age female patient who experienced knee is very swollen and painful, knee is very swollen and painful and body aches with the use of medical device 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 using hylan g-f 20, sodium hyaluronate, injection (dosage, frequency, route, lot unknown). On an unknown date, after unknown latency (less than a week), the patient had body aches (pain), knee was very swollen and painful (injection site joint pain, injection site joint swelling). These events of ), knee was very swollen and painful were leading to disability. Reportedly, the synvisc gave her nearly one year of relief but the week of her annual infiltration was pure hell. The patient had been able to get about home in a wheelchair but by day 7, she can get up to toilet in the night without assistance. The patient wondered if she could have an allergy. Action taken- unknown. Corrective treatment: wheelchair- knee is very swollen and painful, knee is very swollen and painful, not reported for body aches. At time of reporting, the outcome was not recovered / not resolved for the event body aches, was not recovered / not resolved for the event knee is very swollen and painful and was not recovered / not resolved for the event knee is very swollen and painful.
 
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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 Key12367047
MDR Text Key268121779
Report Number2246315-2021-00140
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,foreign,health profe
Type of Report Initial,Followup
Report Date 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
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: 08/25/2021 Patient Sequence Number: 1
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