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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 BRSL015
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Neuropathy (1983); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2021
Event Type  Injury  
Event Description
Legs were beginning to not hold me up [weight bearing difficulty]. Moderate to severe neuropathy [neuropathy]. Withdrew fluid [knee effusion]. Felt strange [feeling strange]. Severe pain all over my body [general body pain]. Case narrative: initial information received from (b)(6) on (b)(6) 2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional. This case involves (b)(6) female patient who experienced moderate to severe neuropathy, had fluid withdrawn, legs were beginning to not hold her up, felt strange and had severe pain all over my body while being treated with the use of medical device hylan g-f 20,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 (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate solution for injection at a dose of 6 ml once (lot - unknown) for osteoarthritis. By the time patient left the doctor's office, her legs were beginning to not hold her up (weight bearing difficulty; onset: (b)(6) 2021; latency: same day; seriousness: intervention required) felt strange (feeling abnormal; onset: (b)(6) 2021; latency: same day) and had severe pain all over body (pain; onset: (b)(6) 2021; latency: same day). The patient went to a doc-in-the-box (urgent care) 3 times and the emergency room (er) 2 times. The doctor who did the injections withdrew fluid (joint effusion; latency: unknown; seriousness: medically significant and intervention required) and injected cortisone on an unknown date in 2021. Now the patient was under treatment by a rheumatologist and was on more medications. A neurologist did 'muscle stim' testing and determined that had moderate to severe neuropathy as a result of the injections (neuropathy peripheral; onset: 2021; latency: unknown; seriousness: medically significant). Action taken: not applicable. The patient was treated with cortisone acetate for weight bearing difficulty; fluid was withdrawn for joint effusion; no other treatment reported. At time of reporting, the outcome was not recovered / not resolved for all 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 Key13018085
MDR Text Key288583208
Report Number2246315-2021-00181
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberBRSL015
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? No Answer Provided
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: 12/16/2021 Patient Sequence Number: 1
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