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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 8RSL029
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Bacterial Infection (1735); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Sanofi company comment dated 23-jan-2021: this case concerns a patient who was on treatment with synvisc one in left knee and had severe staph infection which required hospitalization and 2 clean out surgeries. The plausible causal role of the device cannot be denied, however, more information regarding patient's concurrent clinical presentation, relevant medical history, past drugs, concomitant medications and other risk factors is required for further case assessment.
 
Event Description
Severe staph infection (left knee) [arthritis bacterial] ([staphylococcal infection]). Loss of cartilage and ultimately a loss of function and stability (left knee) [musculoskeletal disorder]. Loss of cartilage and ultimately a loss of function and stability (left knee) [cartilage disorder]. Loss of cartilage and ultimately a loss of function and stability (left knee) [joint instability]. Case narrative: initial information received from united states on 15-jan-2021 from patient (significant) and healthcare professional (non-significant) regarding an unsolicited valid serious case. This case involves adult patient who experienced severe staph infection (left knee), loss of cartilage and ultimately a loss of function and stability (left knee), while he/she was treated with 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. Patient had purchased a number of hylan g-f 20, sodium hyaluronate injections to use overtime. On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate, injection in left knee (dose, frequency, route, indication, batch number: unknown). Information on the batch number was requested. On an unknown date in (b)(6) 2020 (last (b)(6)), patient had a severe staph infection (arthritis bacterial; staphylococcal infection) which resulted in hospitalization, 2 clean out surgeries, a loss of cartilage and ultimately a loss of function and stability (chondropathy, musculoskeletal disorder, joint instability). Patient had 5 unopened, still in the box hylan g-f 20, sodium hyaluronate products that patient was not comfortable using. Patient could not say for sure if the infection was from the product or from an error in the injection. Patient wanted to send the remaining 5 boxes back for a refund and to identify if there was an issue with the batch of the product. Event of arthritis bacterial and its symptom was assessed as serious due to hospitalization and required intervention and was medically significant. Action taken: not applicable for all events. Corrective treatment: clean out surgeries for arthritis bacterial, not reported for rest of the events. Outcome: unknown for all events. A product technical complaint was initiated on 15-jan-2021 for synvisc one for unknown batch number and global ptc number: (b)(4) and results were pending for the same.
 
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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 Key11224091
MDR Text Key230946896
Report Number2246315-2021-00033
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 health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 03/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/01/2021
Device Lot Number8RSL029
Was Device Available for Evaluation? No Answer Provided
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: 01/25/2021 Patient Sequence Number: 1
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