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)

Event Type  Injury  

Event Description

Shortness of breath [shortness of breath] restless leg [legs restless] fatigue [fatigue] blood clotted and not able to run [clot blood] diagnosed with acute pharyngitis [acute pharyngitis] sore throat [sore throat] body aches [general body pain] pain in her thigh after the injection [pain in thigh] rash on her face [rash face] she thinks she is having an allergic reaction to the gel [allergic reaction] complaints of pain (left knee) [injection site joint pain] complaints of swelling (left knee) [injection site joint swelling] case narrative: initial information received from united states on (b)(6) 2022 regarding an unsolicited valid serious case from a consumer/non-hcp.This case involves a 54 years old female patient who had blood clotted and not able to run, shortness of breath, restless leg, fatigue, diagnosed with acute pharyngitis, sore throat, body aches, pain in her thigh after the injection , rash on her face, she thinks she is having an allergic reaction to the gel, complaints of pain (left knee) and complaints of swelling (left knee) while being treated with 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 jun-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 left knee (lot - crsl016b, expiry date: (b)(6) 2025) for knee pain (strength, dose, frequency, route: unknown) 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 jul/aug-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: aug-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 (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.

Manufacturer Narrative

Sanofi company comment dated (b)(6) 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

Shortness of breath [shortness of breath] restless leg [legs restless] fatigue [fatigue] blood clotted and not able to run [clot blood] diagnosed with acute pharyngitis [acute pharyngitis] sore throat [sore throat] body aches [general body pain] pain in her thigh after the injection [pain in thigh] rash on her face [rash face] she thinks she is having an allergic reaction to the gel [allergic reaction] complaints of pain (left knee) [injection site joint pain] complaints of swelling (left knee) [injection site joint swelling] case narrative: initial information received from united states on 17-aug-2022 regarding an unsolicited valid serious case from a consumer/non-hcp (healthcare professional).This case involves a 54 years old female patient who had blood clotted and not able to run, shortness of breath, restless leg, fatigue, diagnosed with acute pharyngitis, sore throat, body aches, pain in her thigh after the injection , rash on her face, she thinks she is having an allergic reaction to the gel, complaints of pain (left knee) and complaints of swelling (left knee) while being treated with 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 (strength: 48 mg/6ml) in left knee (lot - crsl016b, expiry date: 31-mar-2025) for knee pain (dose, frequency, route: unknown).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, intervention required), restless leg (restless legs syndrome, medically significant, intervention required), fatigue (medically significant, intervention required) 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 (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 on (b)(6) 2022 for hylan g-f 20, sodium hyaluronate (lot/batch number: crsl016b; expiry: 31-mar-2025) with global ptc number: (b)(4).Ptc stated "the incoming component inspection, packaging, and quality control documentation for this lot was reviewed.The investigation showed the product met specification at the time of release.It is the requirement to review all finished batch records for specification conformance prior to release.Customer sample was not available for evaluation.Trend analysis: this is the 2nd complaint for crsl016b and 5th complaint for mother lot crsl016.Based on investigation, no capa (corrective action preventive action) required".The final investigation was completed on 03-oct-2022 with summarized conclusion as no assessment possible.Additional information was received on 03-oct-2022 from healthcare professional.Ptc details added.Text amended accordingly.

Manufacturer Narrative

Sanofi company comment dated 23-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.

• 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: 15353856
• MDR Text Key: 299275145
• Report Number: 2246315-2022-00099
• 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: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: CRSL016B
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Other; Required Intervention
• Patient Sex: Female