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

Lot Number CRSL016B

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

Patient Problems Dyspnea (1816); Fatigue (1849); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 26-aug-2022: this case involves a 54 years old female patient who had blood clotted and not able to run, shortness of breath, restless leg, fatigue, after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).Based on the available information, causal relationship between the events and suspect product could not be denied.However, further information regarding patient¿s relevant medical history, past medications, concomitant medications, underlying conditions, injection technique, post injection routine, and other risk factors would aid in better case assessment.

Event Description

Had restless leg [restless legs].Having fatigue [fatigue].Was notified that the blood clotted and not able to run [clot blood].Had shortness of breath [shortness of breath].Acute pharyngitis [acute pharyngitis].Having sore throat [sore throat].Body aches [general body pain].Pain in her thigh after the injection [pain in thigh].Rash on face [rash face].Having and an allergic reaction to the gel [allergic reaction].Complain of pain (right knee) [knee pain].Complains of swelling (right knee) [injection site joint swelling].Complaints of pain (right knee) [injection site joint pain].Case narrative: initial information received on 17-aug-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp from (b)(6).This case is linked with: 2022sa344381 (multiple device).This case involves a 54 years old female patient who had restless leg, having fatigue, was notified that the blood clotted and not able to run, had shortness of breath, acute pharyngitis, having sore throat, body aches, pain in her thigh after the injection, rash on face, having and an allergic reaction to the gel, complain of pain (right knee), complains of swelling (right knee) and complaints of pain (right knee) while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing penicillin allergy and keflex was contraindicated.The reporter mentioned that they saw this patient in (b)(6) 2022 as a new patient and they worked her up for knee pain.On (b)(6) 2022, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) injection in right knee (lot: crsl016b, expiry date: 31-mar-2025; unknown strength, route, frequency, dose) for knee pain.Reportedly, the patient came on (b)(6) 2022 and received bilateral synvisc one injections.She called back (b)(6) 2022 with complaints of pain (injection site joint pain, latency: 2 days) and swelling (injection site joint swelling, latency: 2 days).She was instructed to ice, elevate, and use anti-inflammatory medicine.On (b)(6) 2022, after latency of 9 days, she reached out to her internal medicine doctor and was diagnosed with acute pharyngitis (pharyngitis).She was prescribed keflex.She called the office on (b)(6) 2022 and stated that she thought she was having an allergic reaction to the gel (hypersensitivity; latency: 15 days).Since an unknown date in (b)(6) 2022, after latency of few days, the patient reported having body aches (pain), fatigue and sore throat (oropharyngeal pain).It was charted that physical therapy was being considered.The next day she saw the physician that prescribed keflex and he put a diagnosis of adverse drug reaction.She called back (b)(6) 2022 and said that she was having continued issues.She went to urgent care (b)(6) 2022 and stated that she had pain in her thigh after the injection (pain in extremity; latency: 23 days) and she was having body aches (pain), fatigue, sore throat (oropharyngeal pain), and a rash on her face (rash, latency: 23 days).She tested negative for covid twice and received doxycycline for a sore throat and was placed on keflex that did not help.She was notified that the blood clotted and not able to run (thrombosis, medically significant, onset: (b)(6) 2022, latency: few days).On (b)(6) 2022, after latency of 25 days, she reported to the local emergency department that she had shortness of breath (dyspnoea,medically significant), restless leg (restless legs syndrome, medically significant), fatigue (medically significant) and two rounds of antibiotics.She was negative for covid and strep.Relevant laboratory test results included: sars-cov-2 test - in 2022: negative; streptococcus test - in 2022: negative.Action taken: not applicable for all the events.The patient was treated with cefalexin (keflex) for acute pharyngitis and sore throat; doxycycline for sore throat; instructed to ice, elevate and use anti-inflammatory medicine for complaints of pain and swelling; two rounds of antibiotics for shortness of breath, restless leg, fatigue in local emergency room; not reported for rest of events.At time of reporting, the outcome was unknown for all the events.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Event Description

Had restless leg [restless legs] having fatigue [fatigue] was notified that the blood clotted and not able to run [clot blood] had shortness of breath [shortness of breath] acute pharyngitis [acute pharyngitis] ([sore throat]) body aches [general body pain] pain in her thigh after the injection [pain in thigh] rash on face [rash face] having and an allergic reaction to the gel [allergic reaction] complains of swelling (right knee) [injection site joint swelling] complaints of pain (right knee) [injection site joint pain].Case narrative: initial information received on 17-aug-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp from united states.This case is linked with: (b)(4) (multiple device suspect used for the same patient).This case involves 54 years old female patient who had restless leg, having fatigue, was notified that the blood clotted and not able to run, had shortness of breath, acute pharyngitis, body aches, pain in her thigh after the injection, rash on face, allergic reaction to the gel, complain of pain (right knee), complains of swelling (right knee) and complaints of pain (right knee) while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing penicillin allergy and keflex was contraindicated.The reporter mentioned that they saw this patient in (b)(6) 2022 as a new patient and they worked her up for knee pain.On (b)(6) 2022, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) injection in right knee intra-articularly (lot: crsl016b, expiry date: 31-mar-2025; strength: 48mg/6ml, unknown frequency, dose) for knee pain.Reportedly, since an unknown date in (b)(6) 2022, after latency of few days, the patient reported having body aches (pain), fatigue and sore throat (oropharyngeal pain).It was charted that physical therapy was being considered.The next day she saw the physician that prescribed keflex and he put a diagnosis of adverse drug reaction.The patient came on (b)(6) 2022 and received bilateral synvisc one injections.She called back (b)(6) 2022 after latency of 2 days, with complaints of pain (injection site joint pain) and swelling (injection site joint swelling).She was instructed to ice, elevate, and use anti-inflammatory medicine.On (b)(6) 2022, after latency of 9 days, she reached out to her internal medicine doctor and was diagnosed with acute pharyngitis (pharyngitis).She was prescribed keflex.She called the office on (b)(6) 2022 and stated that she thought she was having an allergic reaction to the gel (hypersensitivity; latency: 15 days).She called back (b)(6) 2022 and said that she was having continued issues.She went to urgent care on (b)(6) 2022 and stated that she had pain in her thigh after the injection (pain in extremity; latency: 23 days) and she was having body aches (pain), fatigue, sore throat (oropharyngeal pain), and a rash on her face (rash, latency: 23 days).She tested negative for covid twice and received doxycycline for a sore throat and was placed on keflex that did not help.She was notified that the blood clotted and not able to run (thrombosis, medically significant onset: (b)(6) 2022, latency: few days).On (b)(6) 2022, after latency of 25 days, she reported to the local emergency department that she had shortness of breath (dyspnoea, medically significant), restless leg (restless legs syndrome, medically significant), fatigue (medically significant) and two rounds of antibiotics.She was negative for covid and strep.Action taken: not applicable for all events.Corrective treatment: the patient was treated with cefalexin (keflex) and doxycycline for acute pharyngitis; instructed to ice, elevate and use anti-inflammatory medicine for complaints of pain and swelling; two rounds of antibiotics for shortness of breath, restless leg, fatigue in local emergency room; not reported for rest of events.Outcome: unknown for all events.A product technical complaint (ptc) was initiated on 17-aug-2022 for synvisc (lot/batch number: crsl016b; expiry date: 31.03.2025) with global ptc number: (b)(4).The sample status of the ptc was not available and the ptc stated: based on the complaint from intake team, there was no quality related defect that would pose as a malfunction.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." defect class has been updated to ii this complaint does not have a quality defect that would attribute to a death or serious injury.The production and quality control documentation for lot # crsl016b expiration date (2025-03) was manufactured on 22apr22 packaged (b)(4) singles was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # crsl016b no capa (corrective and preventive actions) is required.As of 24apr2023 there are 16 complaints on file for lot# crsl016 and all related sublots.3 complaints are on file for lot#crsl016b: (3) adverse event reports.13 complaints are on file for lot#crsl016: (13) adverse event reports.Sanofi will continue to monitor complaints and trending "product event handling" to determine if a capa was required.The final investigation was completed on 09-may-2023 with summarized conclusion as no assessment possible.Additional information was received on 17-aug-2022 from healthcare professional (quality department).Global ptc number and strength were added.Text amended accordingly.Additional information was received on 09-may-2023 from healthcare professional (quality department).Global ptc details added.Text amended accordingly.

Event Description

Had restless leg [restless legs].Having fatigue [fatigue].Was notified that the blood clotted and not able to run [clot blood].Had shortness of breath [shortness of breath].Acute pharyngitis [acute pharyngitis] ([sore throat]).Body aches [general body pain].Pain in her thigh after the injection [pain in thigh].Rash on face [rash face].Having and an allergic reaction to the gel [allergic reaction].Complains of swelling (right knee) [injection site joint swelling].Complaints of pain (right knee) [injection site joint pain].Case narrative: initial information received on 17-aug-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp from united states.This case is linked with: (b)(4) (multiple device suspect used for the same patient).This case involves 54 years old female patient who had restless leg, having fatigue, was notified that the blood clotted and not able to run, had shortness of breath, acute pharyngitis, having sore throat, body aches, pain in her thigh after the injection, rash on face, having and an allergic reaction to the gel, complain of pain (right knee), complains of swelling (right knee) and complaints of pain (right knee) while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing penicillin allergy and keflex was contraindicated.The reporter mentioned that they saw this patient in (b)(6) 2022 as a new patient and they worked her up for knee pain.On (b)(6) 2022, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) injection in right knee intra-articularly (lot: crsl016b, expiry date: 31-mar-2025; strength: 48mg/6ml, unknown frequency, dose) for knee pain.Reportedly, the patient came on (b)(6) 2022 and received bilateral synvisc one injections.She called back (b)(6) 2022 after latency of 2 days, with complaints of pain (injection site joint pain) and swelling (injection site joint swelling).She was instructed to ice, elevate, and use anti-inflammatory medicine.On (b)(6) 2022, after latency of 9 days, she reached out to her internal medicine doctor and was diagnosed with acute pharyngitis (pharyngitis).She was prescribed keflex.She called the office on (b)(6) 2022 and stated that she thought she was having an allergic reaction to the gel (hypersensitivity; latency: 15 days).Since an unknown date in (b)(6) 2022, after latency of few days, the patient reported having body aches (pain), fatigue and sore throat (oropharyngeal pain).It was charted that physical therapy was being considered.The next day she saw the physician that prescribed keflex and he put a diagnosis of adverse drug reaction.She called back (b)(6) 2022 and said that she was having continued issues.She went to urgent care on (b)(6) 2022 and stated that she had pain in her thigh after the injection (pain in extremity; latency: 23 days) and she was having body aches (pain), fatigue, sore throat (oropharyngeal pain), and a rash on her face (rash, latency: 23 days).She tested negative for covid twice and received doxycycline for a sore throat and was placed on keflex that did not help.She was notified that the blood clotted and not able to run (thrombosis, medically significant onset: (b)(6) 2022, latency: few days).On (b)(6) 2022, after latency of 25 days, she reported to the local emergency department that she had shortness of breath (dyspnoea, medically significant), restless leg (restless legs syndrome, medically significant), fatigue (medically significant) and two rounds of antibiotics.She was negative for covid and strep.Action taken: not applicable for all events.Corrective treatment: the patient was treated with cefalexin (keflex) for acute pharyngitis and sore throat; doxycycline for sore throat; instructed to ice, elevate and use anti-inflammatory medicine for complaints of pain and swelling; two rounds of antibiotics for shortness of breath, restless leg, fatigue in local emergency room; not reported for rest of events.Outcome: unknown for all events.A product technical complaint (ptc) was initiated on 17-aug-2022 for synvisc one (lot: crsl016b, expiry date: 31-mar-2025) with global ptc number 100319317.The sample status was not available.Ptc was set in process and results were pending for the same.Additional information was received on 17-aug-2022 from healthcare professional (quality department).Global ptc number and strength were added.Text amended accordingly.

• Brand Name: SYNVISC ONE
• 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: 15353791
• MDR Text Key: 299275771
• Report Number: 2246315-2022-00100
• 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,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: CRSL016B
• 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; Other
• Patient Sex: Female