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

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Discomfort (2330); Loss of consciousness (2418); Swelling/ Edema (4577)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Passed out in the bathroom for an unknown amount of time [passed out].Severe nerve pain in the foot on that leg [nerve pain].Felt discomfort for 3 days after the injection [discomfort].Tremendous pain [pain in leg].Woke to find his knee, leg, and foot on the leg he received the injection on had all swollen up tremendously to the point he could not get a shoe on that foot [swelling of legs].Allergic reaction he is having to an injectable medication [allergic reaction].Injection went fine except it bled profusely when the doctor removed the needle from his knee/ blood from running down his leg [injection site bleeding].Case narrative: initial information received on 10-jun-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp (non-healthcare professional).Country: united states.This case involves a 66 years old male patient who experienced passed out in the bathroom for an unknown amount of time, severe nerve pain in the foot on that leg, felt discomfort for 3 days after the injection, tremendous pain, woke to find his knee, leg, and foot on the leg he received the injection on had all swollen up tremendously to the point he could not get a shoe on that foot, allergic reaction he is having to an injectable medication and injection went fine except it bled profusely when the doctor removed the needle from his knee/ blood from running down his leg with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history included pancreatitis.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing drug hypersensitivity.The patient was taking januvia roughly 6 to 7 years ago.He took it for 9 months before suddenly coming down with severe pancreatitis that nearly killed him.He believed he had a delayed severe allergic reaction to the januvia.In (b)(6) 2022, the patient started using hylan g-f 20, sodium hyaluronate, injection via intra-articular route (in the knee) (with an unknown batch number, strength, dose, frequency, indication and expiration date).Patient received an injection in (b)(6).The injection went fine except it bled profusely when the doctor removed the needle from his knee (injection site haemorrhage; onset date (b)(6) 2022; latency same day).They had to tape gauze to the wound to keep the blood from running down his leg, felt discomfort (discomfort; onset date (b)(6) 2022; latency same day) for 3 days after the injection which he was told was normal, but after about 7 days he passed out in the bathroom for an unknown amount of time, and woke to find his knee, leg, and foot on the leg he received the injection on had all swollen up tremendously to the point he could not get a shoe on that foot.The patient was seeking help regarding an adverse event / allergic reaction he is having to an injectable medication (hypersensitivity; onset date unknown; latency: unknown).He was unable to tell the name of the medication was searching for help regarding medications that are injected into the knee.On an unknown date in 2022 with a latency of about a week after the injection he passed out (loss of consciousness; medically significant) and woke to find his knee, leg, and foot had massively swollen up (peripheral swelling).The swelling had persisted for about 2 months and now includes nerve pain in the foot (neuralgia: onset 2022; latency unknown).He went back to the doctor that administered the shot, but the caller states that the doctor denied they had done anything wrong, and only offered to wrap the knee and leg, which he told them not to because it was in tremendous pain (pain in extremity; onset 2022; unknown latency.He also visited his primary physician who performed ultrasounds and x-rays in case it was a blood clot, but no results.Patient was experiencing what sounds like severe nerve pain in the foot on that leg and he does not know where to turn for assistance.He believes he had a delayed severe allergic reaction to the januvia and that the medication injected into his knee was having a similar reaction.Patient no longer trusted his orthopedic doctor since they still would not advise him on what may have caused the issue.Relevant laboratory test results included: ultrasound scan - in 2022: [no results].X-ray - in 2022: [no results].Action taken: unknown for the events.It was not reported if the patient received a corrective treatment for the events.Outcome: unknown for the events.

Manufacturer Narrative

Sanofi company comment dated 15-jun-2022: this case involves a 66 years old male patient who experienced passed out in the bathroom for an unknown amount of time with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded.However, lack of information of past and concomitant medication, therapy details, any family history and any relevant medical history of patient, any concurrent conditions and indication of the drug precludes comprehensive case assessment.

Manufacturer Narrative

Sanofi company comment for follow up dated 13-jun-2022: this case involves a 66 years old male patient who experienced passed out in the bathroom for an unknown amount of time after the use of depo-medrol.Based on the available information provided regarding this case, causal role of the company suspect product cannot be established as the patient did not receive company suspect product synvisc instead received depo-medrol.

Event Description

Passed out in the bathroom for an unknown amount of time [passed out].Severe nerve pain in the foot on that leg [nerve pain].Felt discomfort for 3 days after the injection [discomfort].Tremendous pain [pain in leg].Woke to find his knee, leg, and foot on the leg he received the injection on had all swollen up tremendously to the point he could not get a shoe on that foot [swelling of legs].Allergic reaction he is having to an injectable medication [allergic reaction].Injection went fine except it bled profusely when the doctor removed the needle from his knee/ blood from running down his leg [injection site bleeding].Case narrative: initial information was received on 10-jun-2022 regarding an unsolicited serious non-case from a consumer/non-hcp (non-healthcare professional).Country: united states.This case involves a 66 years old male patient who experienced passed out in the bathroom for an unknown amount of time, severe nerve pain in the foot on that leg, felt discomfort for 3 days after the injection, tremendous pain, woke to find his knee, leg, and foot on the leg he received the injection on had all swollen up tremendously to the point he could not get a shoe on that foot, allergic reaction he is having to an injectable medication and injection went fine except it bled profusely when the doctor removed the needle from his knee/ blood from running down his leg with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history included pancreatitis.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing drug hypersensitivity.The patient was taking januvia roughly 6 to 7 years ago.He took it for 9 months before suddenly coming down with severe pancreatitis that nearly killed him.He believed he had a delayed severe allergic reaction to the januvia.In (b)(6) 2022, the patient started using hylan g-f 20, sodium hyaluronate, injection via intra-articular route (in the left knee) (with an unknown batch number, strength, dose, frequency, indication and expiration date).Patient received an injection in left knee in (b)(6) and had experienced significant pain and problems walking since that time.He initially thought that he had received synvisc-one, but when he called the administering doctor's office and asked, they said what he received was an injection of depo-medrol.The injection went fine except it bled profusely and blood went everywhere when the doctor removed the needle from his knee (injection site haemorrhage; onset date (b)(6)2022; latency same day).He stated that there was a lot of blood, it went all over his leg and the hcp had difficulty getting it to stop.The hcp had to hold pressure on it, then wrap gauze around his leg 3 times, to maintain pressure, so it wouldn't bleed any more and to keep the blood from running down his leg.He felt discomfort (discomfort; onset date (b)(6) 2022; latency same day) and it hurt for about 3 days, then eased up and after the injection which he was told was normal.He was afraid to take the gauze off.After about 7 days (about a week after he received the injection), he passed out in the bathroom for an unknown amount of time and woke up on the floor of his bathroom.He had "passed out", but he had no memory of even going into the bathroom, he had no idea what had happened, or how long he had been there.He woke to find his knee, leg, and foot on the leg he received the injection on had all swollen up tremendously to the point he could not get a shoe on that foot.When he tried to stand up, "my leg wouldn't work".When he looked down, he saw that his left leg was big.He states that there was "a whole lot" of swelling the patient was seeking help regarding an adverse event / allergic reaction he is having to an injectable medication (hypersensitivity; onset date unknown; latency: unknown).He was unable to tell the name of the medication was searching for help regarding medications that are injected into the knee.On an unknown date in 2022 with a latency of about a week after the injection he passed out (loss of consciousness; medically significant) and woke to find his knee, leg, and foot had massively swollen up (peripheral swelling).The swelling had persisted for about 2 months and now includes nerve pain in the foot (neuralgia: onset 2022; latency unknown).He went back to the doctor that administered the shot, but the caller states that the doctor denied they had done anything wrong that would cause that and he should be more concerned about why he passed out, and doctor only offered to wrap the knee and leg, which he told them not to because it was in tremendous pain (pain in extremity; onset 2022; unknown latency.He also visited his primary physician who performed ultrasounds and x-rays in case it was a blood clot, but no results (showed nothing) and had no idea what could be causing it.Patient was experiencing what sounds like severe nerve pain in the foot on that leg and he does not know where to turn for assistance.He believed he had a delayed severe allergic reaction to the januvia and that the medication injected into his knee was having a similar reaction.Patient no longer trusted his orthopedic doctor since they still would not advise him on what may have caused the issue.Then he and his doctor got into a conversation in which she said she didn't want to be his doctor anymore.He made an appointment with another doctor, who ran labs, he would see that doctor next week.He also went to a "clinic" and got a referral to an orthopedist.He had that appointment next week as well.Relevant laboratory test results included: ultrasound scan - in 2022: [no results].X-ray - in 2022: [no results].Action taken: unknown for the events.It was not reported if the patient received a corrective treatment for the events.Outcome: unknown for the events.Additional information was received on 13-jun-2022 from a patient.This case previously processed as valid was downgraded to non-case because the patient received an injection of depo-medrol but not synvisc.Clinical course was updated.Text amended.Local comments: *downgrade*.

• 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: 14740024
• MDR Text Key: 295060689
• Report Number: 2246315-2022-00062
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2022
• 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 the Reporter a Health Professional?: 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: Male