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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 7RSL019
Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
Patient Problems Erythema (1840); Pain (1994); Arthralgia (2355); No Code Available (3191)
Event Date 11/17/2017
Event Type  Injury  
Event Description
(b)(4). This unsolicited case from united states was received on 08-dec-2017 from a nurse. This case concerns (b)(6) female patient who received treatment with synvisc one and later after 3 days had increased pain and after unknown latency knee was warm to touch. Also device malfunction was identified for the reported lot number. No past drug, medical history, concomitant medication or concurrent condition was provided. On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection once at a dose of 1 df into the left knee for left knee arthritis (batch/ lot number: 7rsl021; expiry date: unknown). On (b)(6) 2017, (latency 3 days), the patient complained of increased pain. The patient was told to rest, ice and elevate and take anti-inflammatory drugs. On (b)(6) 2017, the patient called and said that she was using crutches. It was reported that the patient had had iced. On an unknown date in 2017, after unknown latency, the patient's knee was warm to touch. The patient was been taking paracetamol (tylenol) only. She switched to taking naproxen sodium (aleve). Corrective treatment: rest, ice and elevate and take anti-inflammatory drugs, paracetamol (tylenol naproxen sodium (aleve) for increased pain; ice for knee warm to touch. Outcome: not recovered 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 would be completed, corrective and preventive actions would be implemented pharmacovigilance comment: sanofi company comment dated 08-jan-2017: this case concerns a female patient who received synvisc one injection from the recalled lot for left knee arthritis and later had increased pain and her knee was warm to touch. 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 Key7178142
MDR Text Key97909110
Report Number2246315-2018-00084
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 Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 08/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/01/2020
Device Lot Number7RSL019
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 Received04/09/2018
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/10/2018 Patient Sequence Number: 1
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