MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Synovitis (2094); Sleep Dysfunction (2517)

Event Date 09/01/2017

Event Type  Injury  

Event Description

She is among thousands with the allergy/must be synvisc-one as she is only allergic to one antibiotic [device allergy] ([rash all over], [knee swelling], [pain nos], [swelling arm]).Unable to sleep at night [sleep difficult].Traumatic synovitis [synovitis of knee].Case narrative: initial information was received from (b)(6) on (b)(6) 2021 regarding an unsolicited valid serious case from a patient via call center.This case involves an unknown age female patient who is among thousands with the allergy/must be synvisc-one as she is only allergic to one antibiotic (device allergy), unable to sleep at night and had traumatic synovitis, after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past vaccination(s) and family history were not provided.She had her first synvisc one injection in 2016 and it went very well.The patient was allergic to one antibiotic on an unknown date in (b)(6) 2017, the patient received second synvisc one (hylan g-f 20, sodium hyaluronate) solution for injection, at dose of 6 ml once for osteoarthritis (route, lot - unknown).There will be no information available on the batch number of this case.The next day ((b)(6) 2017) after the injection, the patient had a rash all over the upper half of her body (rash) and unbearable pain (pain).Patient took anti-inflammatories.Her doctor (md) told her that she was among thousands with the allergy (device allergy).Patient also had 2-inch swelling on her knee (joint swelling; latency: unknown) and inside her elbows (peripheral swelling; latency: unknown).Symptoms disappeared on (b)(6) 2020.Pain resumed on (b)(6) 2020.Rash resumed on (b)(6) 2020.Patient was taking paracetamol (tylenol) full dose.She was unable to sleep at night (insomnia; latency: unknown).Patient had since received cortisone shots and physiotherapy sessions that helped a lot.Another doctor told her that if she had others (injections), it would hurt more.Patient went to the hospital on (b)(6) 2020 and underwent testing.They said it must be synvisc-one as she was only allergic to one antibiotic.Patient was also diagnosed with traumatic synovitis (synovitis; latency: unknown).Reportedly, the product information was no longer available.Final diagnosis was she is among thousands with the allergy/must be synvisc-one as she is only allergic to one antibiotic, traumatic synovitis and unable to sleep at night.Action taken: not applicable for all the events.Corrective treatment: anti-inflammatories (unspecified), paracetamol (tylenol), cortisone shots and physiotherapy sessions for device allergy; not reported for rest both events outcome: recovering for device allergy; unknown for rest both events.A product technical complaint (ptc) was initiated and results were pending for the same.

Event Description

She is among thousands with the allergy/must be synvisc-one as she is only allergic to one antibiotic [device allergy] ([rash all over], [knee swelling], [pain nos], [swelling arm]).Unable to sleep at night [sleep difficult].Traumatic synovitis [synovitis of knee].Case narrative: initial information was received from canada on (b)(6) 2021 regarding an unsolicited valid serious case from a patient via call center.This case involves an unknown age female patient who is among thousands with the allergy/must be synvisc-one as she is only allergic to one antibiotic (device allergy), unable to sleep at night and had traumatic synovitis, after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past vaccination(s) and family history were not provided.She had her first synvisc one injection in 2016 and it went very well.The patient was allergic to one antibiotic.On an unknown date in (b)(6) 2017, the patient received second synvisc one (hylan g-f 20, sodium hyaluronate) solution for injection, at dose of 6 ml once for osteoarthritis (route, lot - unknown).There will be no information available on the batch number of this case.The next day (b)(6) 2017) after the injection, the patient had a rash all over the upper half of her body (rash) and unbearable pain (pain).Patient took anti-inflammatories.Her doctor (md) told her that she was among thousands with the allergy (device allergy).Patient also had 2-inch swelling on her knee (joint swelling; latency: unknown) and inside her elbows (peripheral swelling; latency: unknown).Symptoms disappeared on (b)(6) 2020.Pain resumed on (b)(6) 2020.Rash resumed on (b)(6)2020.Patient was taking paracetamol (tylenol) full dose.She was unable to sleep at night (insomnia; latency: unknown).Patient had since received cortisone shots and physiotherapy sessions that helped a lot.Another doctor told her that if she had others (injections), it would hurt more.Patient went to the hospital on (b)(6) 2020 and underwent testing.They said it must be synvisc-one as she was only allergic to one antibiotic.Patient was also diagnosed with traumatic synovitis (synovitis; latency: unknown).Reportedly, the product information was no longer available.Final diagnosis was she is among thousands with the allergy/must be synvisc-one as she is only allergic to one antibiotic, traumatic synovitis and unable to sleep at night.Action taken: not applicable for all the events.Corrective treatment: anti-inflammatories (unspecified), paracetamol (tylenol), cortisone shots and physiotherapy sessions for device allergy; not reported for rest both events outcome: recovering for device allergy; unknown for rest both events product technical complaint (ptc) was initiated with global ptc number (b)(4).On (b)(6) 2021 for product.Batch number; unknown.Device not returned.The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa (corrective and preventive action) 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 (non-conformance report) 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 will continue to monitor adverse events to determine if a capa is required final investigation complete date:12-jan-2021.Follow up information received on 06-jan-2021 from healthcare professional.Global ptc number added.Additional information was received on 12-jan-2021 from healthcare professional.Global ptc results added.Text was amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 11140188
• MDR Text Key: 231619371
• Report Number: 2246315-2021-00021
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention