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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 7RSL021
Device Problem Microbial Contamination of Device (2303)
Patient Problems Pain (1994); Anxiety (2328); Disability (2371); No Code Available (3191)
Event Date 11/01/2017
Event Type  Injury  
Manufacturer Narrative
Sanofi company comment 17-dec-2019. This case concerns a patient who received treatment with synvisc one from the recall lot and later experienced infection and physical impairment. Temporal relationship can be established with the product administration. Furthermore, the concerned lot number has been identified to have malfunction by the company. Therefore, the causal relationship of the events to the products cannot be excluded.
 
Event Description
Immediate adverse reaction and subsequent infection [joint infection], disfigurement/physical impairment [physical impairment], device malfunction [device malfunction], injuries [injury nos], physical pain [pain], mental anguish [anguish]. Case narrative: this case was found to be duplicate of case: (b)(4) (duplicate). Initial information received on 11-dec-2019 from united states regarding an unsolicited valid serious legal case received from a lawyer. This case involves an unknown age male patient who experienced immediate adverse reaction and subsequent infection (latency: unknown), disfigurement/physical impairment (latency: unknown), injuries (latency: unknown), physical pain (latency: unknown) and mental anguish (latency: unknown), with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one). Additionally, event of device malfunction was also added for the identified recall lot. The patient's past medical history included osteoarthritis of his knee. The past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On (b)(6) 2017, the patient who received intra-articular injection of hylan g-f 20, sodium hyaluronate at dosage 1 df, frequency once (batch: 7rsl021) for knee pain which was administered by a healthcare professional. On an unknown date in (b)(6) 2017, after the injection, patient suffered an immediate adverse reaction and subsequent infection (latency: unknown) which eventually resulted in several surgeries, months of therapy and numerous hospitalizations. This event was assessed as serious and led to hospitalization and was medically significant. The manufacturing process resulting in the microbial infestation of the concerned batch number was a producing cause of the injuries (latency: unknown) sustained by the patient and resulted in significant harm. Since the injection, patient experienced physical pain (latency: unknown) (onset: (b)(6) 2017) and mental anguish (latency: unknown) (onset: (b)(6) 2017). During the same time, patient also experienced disfigurement/physical impairment (latency: unknown). This event was assessed as serious and resulted in disability. Action taken: not applicable for all events. Corrective treatment: several surgeries and months of therapy for immediate adverse reaction and subsequent infection; not reported for rest of the events. Outcome: unknown for all events. An investigation summary was initiated as a result of an unexpected increase in the number of labeled adverse events received from us market for synvisc-one lot 7rsl021. The product met all release testing at time of manufacture in june 2017. Retain samples were retested due to the unexpected increase in adverse events. Higher than expected endotoxin results were obtained. In addition, the presence of microbial contamination was also confirmed. The cause of these events is under investigation. Once this investigation is completed, corrective and preventive actions will be implemented.
 
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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 Key9516756
MDR Text Key186825763
Report Number2246315-2019-00316
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Remedial Action Recall
Type of Report Initial
Report Date 12/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
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: 12/24/2019 Patient Sequence Number: 1
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