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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC; MOZ
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GENZYME CORPORATION(RIDGEFIELD) SYNVISC; MOZ Back to Search Results
Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 01/01/2021
Event Type  Injury  
Event Description
Allergic reaction from synvisc [device allergy] ([pruritus aggravated], [burning sensation skin], [crawling sensation of skin], [skin discomfort]) insomnia [insomnia].Case narrative: initial information received from united states on (b)(6) 2021 regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves a (b)(6) years old male patient who was treated with hylan g-f 20, sodium hyaluronate (synvisc) and had allergic reaction from synvisc and insomnia.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2021, the patient started taking synvisc injections at the dose of 2 ml qw (every week) via unknown route (with an unknown batch number) for osteoarthritis in left knee.On (b)(6) 2021, patient received second injection and on (b)(6) 2021, patient received third injection.After the third injection, patient had slight itching all over the body (pruritus, onset: (b)(6) 2021, latency: few days).By the (b)(6) 2021, the itching was unbearable and worse.Patient had itching all over, feeling of skin crawling, burning and feeling of pieces of glass under his skin and allergic reaction to synvisc (pruritus, formication, skin burning sensation, skin discomfort, device allergy) (onset: 2021, latency: few days).Event of device allergy qualified as adverse event of special interest and was assessed as serious as intervention required.On (b)(6) 2021 (latency: 18 days), he experienced insomnia, took melatonin and diphenhydramine hydrochloride (benadryl) together.At 3am on, (b)(6) 2021, patient went to er (emergency room) and received steroids and diphenhydramine hydrochloride.Patient was prescribed methylprednisolone - 4mg and (b)(6) 2021 was day 3 of taking medication.Patient was also prescribed hydroxyzine 25mg - 1 by mouth for 10 days.Patient stated that despite all of the treatment, his side effects are not improving and he was not certain as to the value of synvisc he was received, was highly concerned about the symptoms he was experiencing.Synvisc was not used for the first time.Action taken: not applicable for both events.The patient was treated with melatonin for insomnia, diphenhydramine hydrochloride for both events, methylprednisolone and hydroxyzine for device allergy.At time of reporting, the outcome was not recovered / not resolved for both events.A product technical complaint was initiated and results were pending for the same.
 
Event Description
Allergic reaction from synvisc [device allergy] ([pruritus aggravated], [burning sensation skin], [crawling sensation of skin], [skin discomfort]) insomnia [insomnia].Case narrative: initial information received from united states on 05-may-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves a 41 years old male patient who was treated with hylan g-f 20, sodium hyaluronate (synvisc) and had allergic reaction from synvisc and insomnia.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2021, the patient started taking synvisc injections at the dose of 2 ml qw (every week) via unknown route (with an unknown batch number) for osteoarthritis in left knee.On (b)(6) 2021, patient received second injection and on (b)(6) 2021, patient received third injection.After the third injection, patient had slight itching all over the body (pruritus, onset:(b)(6) 2021, latency: few days).By the (b)(6) 2021, the itching was unbearable and worse.Patient had itching all over, feeling of skin crawling, burning and feeling of pieces of glass under his skin and allergic reaction to synvisc (pruritus, formication, skin burning sensation, skin discomfort, device allergy) (onset: 2021, latency: few days).Event of device allergy qualified as adverse event of special interest and was assessed as serious as intervention required.On (b)(6) 2021 (latency: 18 days), he experienced insomnia, took melatonin and diphenhydramine hydrochloride (benadryl) together.At 3am on, (b)(6) 2021, patient went to er (emergency room) and received steroids and diphenhydramine hydrochloride.Patient was prescribed methylprednisolone - 4mg and (b)(6) 2021 was day 3 of taking medication.Patient was also prescribed hydroxyzine 25mg - 1 by mouth for 10 days.Patient stated that despite all of the treatment, his side effects are not improving and he was not certain as to the value of synvisc he was received, was highly concerned about the symptoms he was experiencing.Synvisc was not used for the first time.Action taken: not applicable for both events.The patient was treated with melatonin for insomnia, diphenhydramine hydrochloride for both events, methylprednisolone and hydroxyzine for device allergy.At time of reporting, the outcome was not recovered/not resolved for both events a product technical complaint (ptc) was initiated on 05-may-2021 for synvisc.Batch number: unknown; comet compliant id number: (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 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.Final investigation complete date was (b)(6) 2021.No safety issues were indicated in this review.Follow up information was received on 05-may-2021 from the other healthcare professional.No significant information added.Additional information was received on 24-may-2021 from other healthcare professional.Global ptc number and ptc results were added.Text amended accordingly.
 
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Brand Name
SYNVISC
Type of Device
MOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
MDR Report Key11810766
MDR Text Key264964866
Report Number2246315-2021-00101
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 consumer,health professional
Type of Report Initial,Followup
Report Date 05/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Lot NumberUNKNOWN
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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