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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE MOZ

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number 7RSL021
Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
Patient Problems Erythema (1840); Fatigue (1849); Fever (1858); Low Blood Pressure/ Hypotension (1914); Muscle Spasm(s) (1966); Muscle Weakness (1967); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)
Event Date 11/01/2017
Event Type  Injury  
Event Description
This unsolicited case from united states was received on 22-dec-2017 from a consumer (patient's wife). This case concerns a (b)(6) male patient who received treatment with synvisc one and later after unknown latency had fever, pain/pain in knee, swelling in knee and fluid in knee. Also device malfunction was identified for the reported lot number. No past drug, concomitant medication or concurrent condition was provided. The medical history included diabetes type ii. He had no known allergies. On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once for osteoarthritis (batch/lot number: 7rsl021; expiry date: unknown) into the left knee. On an unknown date in (b)(6) 2017, soon after receiving the injection, the patient experienced pain and swelling in the knee. The patient was taking hydrocodone bitartrate/ paracetamol (norco) for pain, as well as meloxicam. He was also said to take over the counter medications for pain. On an unknown date in (b)(6) 2017, the patient experienced a fever. His physician was currently in the process of scheduling the patient for aspiration of the affected knee. No lab work had been performed to date. The patient was not hospitalized, and had not seen his physician to date. It was reported that the patient had not been prescribed antibiotics. He had needed a cane for ambulation since the symptoms began. His symptoms were still present, but his fever had resolved corrective treatment: cane for ambulation for swelling in knee; hydrocodone bitartrate/paracetamol (norco), meloxicam, over the counter medications, cane for ambulation for pain/pain in knee; not reported for rest of the events outcome: recovered for fever and not recovered for rest of the events an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the 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 was under investigation. Once this investigation would be completed, corrective and preventive actions would be implemented seriousness criteria: important medical event for device malfunction pharmacovigilance comment: sanofi company comment dated 28-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced fever, pain, fluid and swelling in knee. A 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.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer (Section G)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer Contact
darlene kadel
55 corporate drive, ms 55b-220
a
bridgewater, NJ 08807
9089817289
MDR Report Key7182468
MDR Text Key97984483
Report Number2246315-2017-00577
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
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 12/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/22/2017
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? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/11/2018 Patient Sequence Number: 1
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