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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 Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191)
Event Date 11/01/2017
Event Type  Injury  
Event Description
Difficulty bearing weight [weight bearing difficulty] , device malfunction [device malfunction] , difficulty bending [joint range of motion decreased] , difficulty moving [mobility decreased] , difficulty walking [difficulty in walking] , pain~/severe right knee pain/right knee worse than left knee/right knee had quite sever pain/left knee had pain/stabbing pain/aching pain/continued achiness/throbbing pain [knee pain] , swelling/knee swelling [swelling of knees] , fever [fever] , discomfort [discomfort] , reaction like he has never had before in these knees [local reaction] , weakness [weakness] , bruising [bruising]. Case narrative: based on additional information received on 10-may-2018, this case initially considered as non-serious was upgraded to serious [required intervention for pain/severe right knee pain/right knee worse than left knee/right knee had quite sever pain/left knee had pain/stabbing pain/aching pain/continued achiness/throbbing pain]. Additionally, this case became medically confirmed by physician. This spontaneous case from united states was received on 26-dec-2017 from the patient this case concerns a (b)(6) male patient who initiated treatment with synvisc one and after a few hours had swelling, pain/severe right knee pain/right knee worse than left knee/right knee had quite sever pain/left knee had pain/stabbing pain/aching pain/continued achiness/throbbing pain, difficulty bearing weight, difficulty moving, device malfunction and after 01 day experienced fever, discomfort, difficulty walking, difficulty bending and bruising, after few days had weakness, reaction like he has never had before in these knees medical history included (family history-hypertension, diabetes mellitus, arthritis), tonsillectomy (1979), ibd, apnea, headaches, heartburn, osteoarthritis and polycythemia. Patient was allergic to diphenhydramine hydrochloride (benadryl), naproxen sodium (aleve) and sulfa. Concomitant medication included lisinopril for high blood pressure, rosuvastatin calcium (crestor) and gemfibrozil for high cholesterol, dicycloverine (dicyclomine) and ibuprofen for pain, pravastatin sodium (pravastatin), tramadol hydrochloride (tramadol), gabapentin, tizanidine, orphenadrine citrate, fluticasone, clindamycin phosphate (clindamycin), cyanocobalamin (vitamin b12), rosuvastatin, hydrocortisone (proctosol), lansoprazole (prevacid), benzyl benzoate/bismuth hydroxide/bismuth subgallate/hydrocortisone acetate/myroxylon balsamum var. Pereirae balsam/resorcinol/zinc oxide (anusol-hc), testosterone (androgel), promiseb topical cream. On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once (lot details: 7rsl021; expiry date: not reported) for osteoarthritis. On the same day, the patient completed the treatment. On the same day patient had device malfunction. On an unknown date (b)(6) 2017, within 24 hours, he developed pain, swelling and difficulty moving or bearing weight. He states that both knees are affected but the right more than left. On (b)(6) 2017, 01 days after the event, the patient experienced fever, discomfort, severe right knee pain, difficulty walking, difficulty walking/bending and bruising. On unknown date of (b)(6) 2017 patient had weakness and reaction like he has never had before in these knees corrective treatment: ibuprofen, cortisone and cold pack for difficulty bending, difficulty moving, difficulty bearing weight, fever, discomfort, difficulty walking, pain/severe right knee pain/right knee worse than left knee/right knee had quite sever pain/left knee had pain/stabbing pain/aching pain/continued achiness/throbbing pain, swelling, difficulty bending and bruising; not reported for rest of the events. Outcome: recovering for fever, difficulty moving, difficulty bearing weight, pain/severe right knee pain/right knee worse than left knee/right knee had quite sever pain/left knee had pain/stabbing pain/aching pain/continued achiness/throbbing pain, swelling; not recovered for rest of the events; unknown for device malfunction, weakness, reaction like he has never had before in these knees. Seriousness criteria: required intervention for pain/severe right knee pain/right knee worse than left knee/right knee had quite sever pain/left knee had pain/stabbing pain/aching pain/continued achiness/throbbing pain. (b)(4). The product lot number was not provided; therefore, a batch record review is not possible. Based on the lack of information provided, no capa is required. It is the requirement to review all finished batch records for specification conformance prior to release. Any out of specification result is 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 has not indicated any safety issue. Sanofi will continue to monitor adverse events to determine if a capa is required. Additional information was received on 09-feb-2018. The global ptc number and the results were added. Additional information was received on 20-feb-2018 from a patient. Event of discomfort, difficulty walking, difficulty bending and bruising were added with details. Therapy start date and indication were added. Concomitant medication, past drug, medical history and concurrent condition was added. Event start date was updated for fever. Corrective treatment for the event of fever, discomfort, difficulty walking, pain/severe right knee pain was added. Clinical course updated. Text amended accordingly. Additional information was received on 10-may-2018 from physician. This case initially considered as non-serious was upgraded to serious [required intervention for pain/severe right knee pain/right knee worse than left knee/right knee had quite sever pain/left knee had pain/stabbing pain/aching pain/continued achiness/throbbing pain]. Additionally, this case became medically confirmed. Verbatim and seriousness updated for pain/severe right knee pain/right knee worse than left knee/right knee had quite sever pain/left knee had pain/stabbing pain/aching pain/continued achiness/throbbing pain. Events of device malfunction, weakness, reaction like he has never had before in these knees. Lot no. Added. Concomitant medications and medical history was added. Clinical course was updated and text was amended accordingly.
 
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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
MDR Report Key7584389
MDR Text Key110574735
Report Number2246315-2018-00482
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 12/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
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: 06/08/2018 Patient Sequence Number: 1
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