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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID Back to Search Results
Lot Number 7RSL021
Device Problem Device Contamination With Biological Material (2908)
Patient Problems Arthralgia (2355); Joint Swelling (2356)
Event Type  malfunction  
Event Description
This case is cross-referred to case id: (b)(4) (cluster) this unsolicited case from united states was received on (b)(6) 2018 from a physician. This case concerns a 3 patients (demographics: not provided) who received treatment with synvisc one injection and later after unknown latency developed pain and swelling in the knee. Also, device malfunction was identified for the reported lot number. No relevant past drug, medical history, concomitant medications and concurrent conditions were reported. On an unknown date in (b)(6) 2017, the patients initiated treatment with intra- articular synvisc one injection (dose, frequency, indication: not provided; batch/lot: 7rsl021 and expiration date: not provided). On an unspecified date, after unknown latency, the patients complained of pain and swelling in the knee. All three patients received corticosteroids as treatment. It was reported that three patients have responded to the corticosteroids. It was unknown whether patient received any other injections prior to treatment. Patients was seen two days after the injection and was for complaints of pain and swelling. It was unknown if the patient engaged in any activities such as tennis or jogging soon after the injection. Patients were known to have pain and swelling in the affected knee. Measurements of the knee circumference was not known. It was unknown if the patients were able to bear weight before and after the injection. It was unknown as the level of pain that the patients complained of. It was unknown if the patients had a fever. Blood work were done but, results and specific type of lab work completed was unknown. Cultures were completed but, results of culture were unknown. The patients had been treated with corticosteroids. The patient had not been hospitalized but, stated that the providers office noted that the patient may require surgery on the knee as a result of the injection. The three of the patients had recovered. Action taken: unknown corrective treatment: corticosteroids for pain and swelling in the knee outcome: recovered for all the events seriousness criteria: required intervention for all 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 is completed, corrective and preventive actions would be implemented.
 
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Brand NameSYNVISC ONE
Type of DeviceINTRA-ARTICULAR HYALURONIC ACID
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleadantview terrace
ridgefield NJ 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive
55b-220a
bridgewater, NJ 08807
9089817289
MDR Report Key7288210
MDR Text Key101025177
Report Number2246315-2018-00330
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 health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 02/09/2018
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? No
Device Operator Other
Device Lot Number7RSL021
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/09/2018
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/22/2018 Patient Sequence Number: 1
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