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Lot Number 7RSL021
Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
Patient Problem No Code Available (3191)
Event Date 12/08/2017
Event Type  Injury  
Event Description
Based on additional information received on 21-mar- 2018, this case initially considered as non-serious was upgraded to serious as earlier added non-serious event unable to walk at all on that leg updated as serious event (disability). Also additional serious event of device malfunction was added with details (disability). This unsolicited case from united states was received on 12-jan-2018 from the patient. This case concerns a (b)(6) female patient who received treatment with synvisc one injection and after few hours the patient experienced significant swelling/ swelling was mid quadriceps and down to my ankle and had pain; the same day patient was unable to walk at all on that leg, unable to bear weight, did not feel well/slept whole weekend because of not feeling well; after unknown latencies patient had atrophy of quadriceps, pain in left leg and swelling of left leg and a device malfunction was noted for reported lot number. No relevant medical history, past drugs and concurrent condition was reported. On (b)(6) 2017, at 08:00 in the morning the patient received treatment with intra-articular synvisc one injection (dose, indication, frequency and expiration date: not reported; batch/lot number: 7rsl021). By 2 pm in the afternoon patient had significant swelling and pain (latency: few hours). Patient was unable to walk at all on that leg due to the pain (latency: 0 day). By 6 pm that evening patient could not use the quadriceps or calf muscles. The swelling was up to the mid quadriceps and down to the ankle. Patient was unable to bear any weight and did not feel well (latency: 0 day). For the next 2 days, patient had 8/10 pain and slept most of the weekend due to not feeling well. On (b)(6) 2017, patient contacted the medical doctor (md) and was told to ice and elevate. On (b)(6) 2017 (wednesday; 6 days later) patient went in to see the doctor because patient still was unable to bear weight or fire the quadriceps or calf muscle. At this point patient was told about the product recall. It took another week to be able to walk with one crutch. Patient missed 4 weeks of work because by the time patient could finally bear weight. Patient had atrophy of my quadriceps. Patient was still working to rebuild the quadriceps. It was reported that, as a result of the synvisc one injection, patient had suffered, among other damages, pain and swelling of her left leg (both on unknown dates, after unknown latencies), medical expenses and wage loss action taken: unknown corrective treatment: ice and elevate for significant swelling/swelling was mid quadriceps and down to my ankle; using cutch for unable to walk at all on that leg; not reported for rest outcome: not recovered for unable to bear weight and device malfunction; unknown for rest a pharmaceutical technical complaint (ptc) was initiated with (b)(4). The product lot number was not provided; therefore, a batch record review was not possible. Based on the lack of information provided, no capa was required. It was the requirement to review all finished batch records for specification conformance prior to release. Any out of specification result was identified and mitigated through the ncr process. Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals. This review had not indicated any safety issue. Sanofi would continue to monitor adverse events to determine if a capa was required. Seriousness criteria: disability for unable to walk at all on that leg and device malfunction additional information was received on 18-jan-2018. Global ptc number and ptc results added. Text was amended accordingly. Follow up was received on 18-jan-2018. No new information was received. Additional information was received on 21-mar-2018 from senior legal specialist. This case initially considered as non-serious was upgraded to serious as earlier added non-serious event unable to walk at all on that leg updated as serious event (disability). Also additional serious event of device malfunction was added with details (disability). Suspect drug synvisc one batch/lot number added. Additional events of device malfunction, pain in left leg and swelling of left leg were added with details. Patient age, gender and date of birth added. Clinical course was updated. Text amended accordingly. Pharmacovigilance comment: sanofi company comment dated 30-mar-2018: this case concerns a patient who received synvisc one injection from the recalled lot and later experienced pain, peripheral swelling and difficulty in walking. Since events occured on the same day of product administration a temporal relationship can be established with the product. Furthermore, the concerned lot number has been identified to have malfunction by the company. However, due to lack of information regarding medical history, concomitant medications, investigation details and past drugs complete medical assessment of the case is difficult. Therefore, the causal relationship of the events to the products cannot be excluded.
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Type of DeviceMOZ
Manufacturer (Section D)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer (Section G)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
bridgewater, NJ 08807
MDR Report Key7401973
MDR Text Key105265504
Report Number2246315-2018-00429
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 02/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2018
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? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/05/2018
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: 04/06/2018 Patient Sequence Number: 1