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

Lot Number UNKNOWN

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

Patient Problems Unspecified Infection (1930); Pain (1994); Convulsion/Seizure (4406); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Was hospitalized with an infection right knee [joint infection].Has had seizures [seizures].His arms and hands are swollen [swollen arm].Arms and hands are painful [pain in arm].Husband is now an invalid [invalid].Has fallen [fall].Broke ribs [rib fracture].Usually give 3 shots but he is going to give it all in one [intentional deviation from dosage regimen].Case narrative: initial information received on 28-apr-2022 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp (non-healthcare professional).This case involves a 66 years old male patient who experienced was hospitalized with an infection right knee, has had seizures, husband is now an invalid, has fallen, broke ribs, his arms and hands are swollen, arms and hands are painful and usually give 3 shots but he is going to give it all in one with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection dosage, route unknown (lot, expiry date - unknown) for unknown indication.The information regarding lot number was requested.The patient was not sure if it was synvisc or synvisc-one but the doctor said prior to the injection they usually give 3 shots but he was going to give it all in one (intentional product use issue).The patient received the injection in his right knee and 4-5 days later she was hospitalized with an infection (arthritis infective; medically significant; start date unknown) and had to have knee wash surgery.Since receiving hylan g f 20 he had seizures (seizure ; medically significant and start date unknown), he has fallen (fall; start date and latency unknown) and broke ribs (rib fracture; latency unknown), his arms and hands were swollen and painful (pain in extremity, peripheral swelling; intervention required; start date and latency unknown)and he had received steroids time and time again.Reportedly, the arms were painful and starting to swell again, could not open a bottle of water and patient was now an invalid (disability).They had been to the rheumatologist, cardiologist, nephrologist and none of the doctors could help.Corrective treatment: knee wash surgery for was hospitalized with an infection right knee, steroids for his arms and hands are swollen, arms and hands are painful and not reported for rest.At time of reporting, the outcome was unknown for all events.A product technical complaint (ptc) was initiated on 28-apr-2022 for synvisc one (lot number unknown) with global ptc number 100221531 and investigation was in process.Follow up information was received on 28-apr-2022 from the healthcare professional.Global ptc number was added.No significant information was received.Based on the information received on 28-apr-2022.The suspect product was recoded.Text amended accordingly.

Event Description

Was hospitalized with an infection right knee [joint infection].Has had seizures [seizures].His arms and hands are swollen [swollen arm].Arms and hands are painful [pain in arm].Husband is now an invalid [invalid].Has fallen [fall].Broke ribs [rib fracture].Usually give 3 shots but he is going to give it all in one [intentional deviation from dosage regimen].Case narrative: initial information received on 28-apr-2022 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp (non-healthcare professional).This case involves a 66 years old male patient who experienced was hospitalized with an infection right knee, has had seizures, husband is now an invalid, has fallen, broke ribs, his arms and hands are swollen, arms and hands are painful and usually give 3 shots but he is going to give it all in one with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection dosage, route unknown (lot, expiry date - unknown, strength: 16 mg/2ml) for unknown indication.The information regarding lot number was requested.The patient was not sure if it was synvisc or synvisc-one but the doctor said prior to the injection they usually give 3 shots but he was going to give it all in one (intentional product use issue).The patient received the injection in his right knee and 4-5 days later she was hospitalized with an infection (arthritis infective; medically significant; start date unknown) and had to have knee wash surgery.Since receiving hylan g f 20 he had seizures (seizure ; medically significant and start date unknown), he has fallen (fall; start date and latency unknown) and broke ribs (rib fracture; latency unknown), his arms and hands were swollen and painful (pain in extremity, peripheral swelling; intervention required; start date and latency unknown)and he had received steroids time and time again.Reportedly, the arms were painful and starting to swell again, could not open a bottle of water and patient was now an invalid (disability).They had been to the rheumatologist, cardiologist, nephrologist and none of the doctors could help.Corrective treatment: knee wash surgery for was hospitalized with an infection right knee, steroids for his arms and hands are swollen, arms and hands are painful and not reported for rest.At time of reporting, the outcome was unknown for all events.A product technical complaint was initiated on 28-apr-2022 for synvisc (batch number: unknown) with global ptc number: (b)(4).The status of sample was not available and ptc stated 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.(b)(4) 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 determine if a capa is required.The final investigation was completed on 29-jul-2022 with summarized conclusion as no assessment possible.Follow up information was received on 28-apr-2022 from the healthcare professional.Global ptc number was added.No significant information was received.Based on the information received on 28-apr-2022.The suspect product was recoded.Text amended accordingly.Additional information was received on 29-jul-2022 from other health care professional from quality department: ptc result and strength of synvisc was added.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 14672967
• MDR Text Key: 294905049
• Report Number: 2246315-2022-00061
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Disability; Other
• Patient Sex: Male