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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 Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Atrial Fibrillation (1729); Unspecified Infection (1930); Pain (1994); Thyroid Problems (2102); Arthralgia (2355); Disability (2371); Joint Disorder (2373); No Code Available (3191)
Event Date 01/01/2017
Event Type  Injury  
Event Description
This unsolicited case from united states was received on (b)(6) 2018 from the physician. This case concerns a female patient with unspecified age who received treatment with synvisc one injection and after unknown latency the patient developed an infection in her knee. No relevant medical history, past drugs and concurrent condition was reported. On an unknown date, the patient received treatment with intra-articular synvisc one injection at the once (dose, indication, lot number and expiration date: not reported). On an unknown date, after unknown latency of receiving the injection, the patient developed an infection in her knee requiring hospitalization. The preliminary investigation revealed that the cause of the infection was due to contarnination of the synvisc one. Corrective treatment: not reported a pharmaceutical technical complaint (ptc) was initiated and results were pending for the same. Seriousness criterion: in-patient hospitalization pharmacovigilance comment: sanofi company comment dated 08-feb-2018: this case concerns a female patient who received injection synvsic one and was hospitalized with knee infection. The role of synvisc one cannot be denied for the occurrence of the event based upon the temporal relationship. However, the information regarding patient's medical history, concurrent conditions, concomitant medications and other risk factors will aid in comprehensive assessment of this case.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer Contact
darlene kadel
55 corporate drive, ms 55b-220
a
bridgewater, NJ 08807
9089817289
MDR Report Key7288215
MDR Text Key100652209
Report Number2246315-2018-00331
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 03/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/28/2018
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: 02/22/2018 Patient Sequence Number: 1
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