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

Lot Number UNKNOWN

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

Patient Problems Hypoesthesia, Foot/Leg (2354); Disability (2371); Reaction, Injection Site (2442); No Code Available (3191)

Event Type  Injury  

Event Description

Bedridden [bedridden] ; literally cannot stand up [difficulty in standing] ; can't walk [gait disturbance] ; bottom of his right foot went numb [numbness in feet] ; right knee felt weak [discomfort in joints] ; very painful [injection site pain] ; doctor gave him cortisone with synvisc [device use error].Case narrative: initial information received from united states on (b)(6) 2018 regarding an unsolicited valid serious case received from the patient.This case involves an unknown age male patient who became bedridden, literally cannot stand up, can't walk, bottom of his right foot went numb, right knee felt weak, injection was very painful and doctor gave him cortisone with synvisc (device use error) unknown latency after the use of medical device synvisc.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date (over last 2 years), the patient started using intra-articular synvisc injection dosage unknown (lot - unknown) for unknown indication.Patient reported that the second and third injection were very painful to the point that patient literally cannot stand up and cannot walk.Patient stated that when he got the last one, about 6 months ago, he was bedridden for 4 days.The doctor had to call in an order for methadone hydrochloride (methadone) for patient to handle the pain.Patient stated that the bottom of the right foot went numb and the right knee felt weak as well.Later, the sensations resolved.This event of bedridden was assessed as disability.Final diagnosis was doctor gave him cortisone with synvisc, very painful, right knee felt weak, bottom of his right foot went numb, can't walk, literally cannot stand up and bedridden.Action taken was unknown.It was reported that the patient received methadone hydrochloride as a corrective treatment for very painful and corrective treatment was not reported for rest.The patient outcome was reported as recovered / resolved on an unknown date for bottom of his right foot went numb and right knee felt weak unknown for very painful and unknown for rest a product technical complaint was initiated on 18-jun-2018 for synvisc one, batch number: unknown, global ptc number: (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 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 had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Seriousness criterion: disability for bedridden additional information was received on 18-jun-2018.The global ptc number with ptc results was added.Text was amended accordingly.

Event Description

Bedridden [bedridden].Literally cannot stand up [difficulty in standing].Can't walk [gait disturbance].Bottom of his right foot went numb [numbness in feet].Right knee felt weak [discomfort in joints].Very painful [injection site pain].Doctor gave him cortisone with synvisc [device use error].Case narrative: initial information received from united states on (b)(6) 2018 regarding an unsolicited valid serious case received from the patient.This case involves an unknown age male patient who became bedridden, literally cannot stand up, can't walk, bottom of his right foot went numb, right knee felt weak, injection was very painful and doctor gave him cortisone with synvisc (device use error) unknown latency after the use of medical device synvisc.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date (over last 2 years), the patient started using intra-articular synvisc injection dosage unknown (lot - unknown) for unknown indication.Patient reported that the second and third injection were very painful to the point that patient literally cannot stand up and cannot walk.Patient stated that when he got the last one, about 6 months ago, he was bedridden for 4 days.The doctor had to call in an order for methadone hydrochloride (methadone) for patient to handle the pain.Patient stated that the bottom of the right foot went numb and the right knee felt weak as well.Later, the sensations resolved.This event of bedridden was assessed as disability.Final diagnosis was doctor gave him cortisone with synvisc, very painful, right knee felt weak, bottom of his right foot went numb, can't walk, literally cannot stand up and bedridden.Action taken was unknown.It was reported that the patient received methadone hydrochloride as a corrective treatment for very painful and corrective treatment was not reported for rest.The patient outcome was reported as recovered / resolved on an unknown date for bottom of his right foot went numb and right knee felt weak unknown for very painful and unknown for rest.A product technical complaint was initiated on 18-jun-2018 for synvisc one, batch number: unknown, global ptc number: 54302.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 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 had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Seriousness criterion: disability for bedridden.Additional information was received on 18-jun-2018.The global ptc number with ptc results was added.Text was amended accordingly.Upon internal review on 09-jan-2019 processed with clock start date of 18-jun-2018 the malfunction field previously captured as yes was removed.

Manufacturer Narrative

Sanofi company comment dated 18-jun-2018: the follow up information received does not change the previous case assessment.This case concerns a male patient who received treatment with synvisc and injection was very painful, patient became bedridden, literally cannot stand up, can't walk, bottom of his right foot went numb, right knee felt weak.Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded.Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• MDR Report Key: 8200328
• MDR Text Key: 131915667
• Report Number: 2246315-2018-00831
• 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
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention