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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Pain (1994); Swelling (2091); Weakness (2145); Arthralgia (2355); Joint Swelling (2356); Sleep Dysfunction (2517); No Code Available (3191)
Event Type  Injury  
Event Description
Can't travel anymore and is almost home-ridden/she can not clean her house and was very independent prior to this/can not bend down, can't play the piano, can't write, can't get dressed [activities of daily living impaired]. Having stiffness like she has "never had in her life"/her hands are even stiff since the last injection and she has trouble holding a fork and knife [stiffness]. She didn't sleep at all that night [sleeplessness]. Debilitating pain in shoulders, elbows, hands, hips and ankles [shoulder pain]. Debilitating pain in shoulders, elbows, hands, hips and ankles [pain in hand]. Doesn't have any quality of life [quality of life decreased]. Increased fatigue [fatigue aggravated]. Feels like she has been struck by lightening/feel lousy [feeling abnormal]. Too weak to drive/ blew up my energy/ no energy [weakness]. She could sleep 22 hours [sleep excessive]. Can't go down her basement because her knees (right) don't bend/can't go down steps [joint range of motion decreased]. Constant pain in skeletal system [skeletal pain]. 1000% worse than before [condition worsened]. Crying/cry all the time [crying]. Cortisone affects her eyes [eye disorder nos]. Enbrel and other medications taken for rheumatoid arthritis affects her stomach [stomach discomfort]. Slow now [slow movement]. Pain all over [pain]. Something wrong with her hands [unspecified disorder of hand joint]. She had swelling above knee down to ankle/leg was swollen triple size [swelling of legs]. She can't walk [unable to walk]. Debilitating pain in shoulders, elbows, hands, hips and ankles [joint pain]. Her right knee started swelling immediately/by morning her knee were double in size/severe swelling [swelling of r knee]. She walked to the car and barely made it she was in so much pain/she still has the pain/severe right knee pain [aching (r) knee] ([device use in unapproved indication]). Had a reaction after shot/ it has been a year and she messed up [unevaluable event]. Case narrative: based on additional information received on 18-may-2020, the case initially assessed as non-serious was upgraded to serious (disability for can't travel anymore and is almost home-ridden/she can not clean her house and was very independent prior to this/can not bend down, can't play the piano, can't write, can't get dressed). This case was linked to case (b)(4) (multiple devices for same patient). Initial information received on 13-sep-2019 from united states regarding an unsolicited valid serious case received from a non-healthcare professional. This case involves a (b)(6) female patient who can't travel anymore and is almost home-ridden/she can not clean her house and was very independent prior to this/can not bend down, can't play the piano, can't write, can't get dressed, having stiffness like she has "never had in her life"/her hands are even stiff since the last injection and she has trouble holding a fork and knife, she didn't sleep at all that night, she can't walk, she walked to the car and barely made it she was in so much pain/she still has the pain/severe right knee pain, her right knee started swelling immediately/by morning her knee were double in size/severe swelling, debilitating pain in shoulders, elbows, hands, hips and ankles, doesn't have any quality of life, increased fatigue, feels like she has been struck by lightening/feel lousy, too weak to drive/blew up my energy/ no energy, she could sleep 22 hours, can't go down her basement because her knees (right) don't bend/can't go down steps, she had swelling above knee down to ankle/leg was swollen triple size, constant pain in skeletal system and 1000% worse than before, crying/cry all the time, cortisone affects her eyes, enbrel and other medications taken for rheumatoid arthritis affects her stomach, slow now, pain all over, something wrong with her hands, had a reaction after shot/ it has been a year and she messed up while she used the medical device hylan g-f 20, sodium hyaluronate (synvisc one), cortisone (cortisone), etanercept (enbrel) and other medications (unspecified) the patient's past medical treatment included she had years ago her first hylan injection (doesn't know the name) 3 shots in both knees and tolerated it well, 2 years ago had hylan g-f 20, sodium hyaluronate and tolerated that well. The patient's past medical history included car accident and arthroscopic surgery on her left knee. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient has been walking with a walker. She also reports vaccines cause autism. Patient had vaccinations in 1944 as a child for prevention, gardasil was causing problems and as a child she spent 13 days in hospital after vaccines and had problems with her legs and developed rheumatoid arthritis and she was not even going to take a flu shot and never has. Patient reported that she had a friend who used bextra and bled to death and in 2002 her friend took vioxx died from it. She had colloidal silver as concomitant and reported was a wonderful product which treats (b)(6). On (b)(6) 2019, the patient started using hylan g-f 20, sodium hyaluronate, injection via intra-articular route, at dose of 6 ml once (lot - unknown) for rheumatoid arthritis in right knee (product used for unapproved indication). On an unknown date, patient started treatment with cortisone (dose, route, frequency, formulation and batch number unknown) for unknown indication. On an unknown date, patient started treatment with etanercept and other medications (unspecified) (dose, route, frequency, formulation and batch number unknown) for rheumatoid arthritis. Information on the batch number was requested. On same day after the injection when she walked to the car and barely made it she was in so much pain and her knees started swelling immediately (latency: 0 day). Patient reported that she would have gone back in the office to tell them, but they were closed. Patient didn't sleep at all that night and by morning her knees were double in size (latency: 0 day). She contacted the doctor who told her that was caused by her rheumatoid arthritis and she never going to that doctor again and used to take oxycodone hydrochloride (oxycontin) for pain when she had to stand all day in her job. On an unknown date, after unknown latency, patient reported that had ruined her summer since she can't walk and was in so much pain and having stiffness like she had never had in her life and mentioned that the swelling was gone now but she still has the pain and her hands are even stiff since the last injection and she has trouble holding a fork and knife. The patient felt there was some change to the device that has caused these issues. Patient had severe reaction on both knees; severe swelling and pain right after getting injections. Patient informed that hylan g-f 20, sodium hyaluronate was not approved for rheumatoid arthritis and her doctor never told her that it wasn't approved with her condition and should never have given her the injection since it was not approved. Consumer has tried to contact lawyers and the fda (food and drug administration) but was unable to get answers due to covid-19. Since then, patient cannot walk or bend over, was 1000% worse than before (onset and latency: unknown). Patient had been in debilitating pain since the injection. Patient had debilitating pain in hips, shoulders, hands, elbows and ankles (onset and latency: unknown) and never had that type of pain before the injection. On an unknown date, after unknown latency, patient was going to drive but her whole life has changed since, she can't travel anymore and is almost home-ridden. Her life totally changed for the worse. She reports she can't get dressed, felt lousy, blew up her energy, cannot bend down, can't play the piano, can't write, cannot clean her house, was too weak to drive, and was very independent prior to this (onset, latency: unknown; seriousness criteria: disability). She said now she could sleep 22 hours and wears a nightgown and was ready for the glue factory (onset, latency: unknown). Patient needs some help and it was worse thing that happened to her. Patient doesn't have any quality of life after getting these injections, had increased fatigue, felt like she has been struck by lightning. Her primary care doctor won't provide pain medication. Patient went to pain clinic, but they will only provide oxycodone hydrochloride and want to give injections to the knees but she has refused. Patient was using hemp oils which only help relax. She can't go down her basement because her knees don't bend (onset, latency: unknown). She needs to get another steroid injection but they are expensive. Patient wanted to know if there was a "slush fund for victims". She reports she had swelling above knee down to ankle and constant pain in skeletal system (onset and latency: unknown). She has had to use chronic pain medication. On an unknown date, after unknown latency, patient was slow, crying, no energy, could not go down steps, something wrong with her hands, her leg was swollen triple in size and had pain all over. Patient also had a reaction after shot and doctor did not inform her that it was not fda approved and it had been a year that she was messed up. On an unknown date, after unknown latency, patient affected her eyes due to cortisone and her stomach got affected as she was also taking enbrel and other medications for rheumatoid arthritis and she was not taking them anymore. Action taken: not applicable for all events. Corrective treatment: oxycodone hydrochloride (oxycontin), hemp oil, chronic pain medications for she walked to the car and barely made it she was in so much pain/she still has the pain/severe right knee pain; chronic pain medications for constant pain in skeletal system, debilitating pain in shoulders, elbows, hands, hips and ankles; not reported for rest of the events outcome: recovered for her right knee started swelling immediately/by morning her knee were double in size/severe swelling; not recovered for she walked to the car and barely made it she was in so much pain/she still has the pain/severe right knee pain; unknown for rest of the events a product technical complaint was initiated on 18-sep-2019 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 lack of information provided, no capa was required. It was the requirement to review all finished batch records for specification conformation 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 surveillance effort to detect safety signals. This review did not indicate any safety issue. Sanofi would continue to monitor adverse events to determine if a capa was required. Final investigation complete date: 18-sep-2019. Additional information received on 18-sep-2019. Investigation summary received and ptc results added. Additional information was received on 18-may-2020 from patient. Medical history and concomitant medications updated. Events of can't travel anymore and is almost home-ridden/she can not clean her house and was very independent prior to this/can not bend down, can't play the piano, can't write, can't get dressed, debilitating pain in shoulders, elbows, hands, hips and ankles, doesn't have any quality of life, increased fatigue, feels like she has been struck by lightening/feel lousy, too weak to drive/blew up my energy, she could sleep 22 hours, can't go down her basement because her knees (right) don't bend, she had swelling above knee down to ankle, constant pain in skeletal system and 1000% worse than before were added with details. Verbatim for events she walked to the car and barely made it she was in so much pain/she still has the pain and her right knee started swelling immediately/by morning her knee were double in size updated to she walked to the car and barely made it she was in so much pain/she still has the pain/severe right knee pain and her right knee started swelling immediately/by morning her knee were double in size/severe swelling respectively. Case upgraded to serious. Clinical course updated. Text amended accordingly. Additional information received on 21-may-2020 from patient. Co suspect of cortisone (cortisone), etanercept (enbrel) and other medications (unspecified) added. Events of crying/cry all the time, cortisone affects her eyes, enbrel and other medications taken for rheumatoid arthritis affects her stomach, slow now, pain all over, something wrong with her hands, had a reaction after shot/ it has been a year and she messed up added. Verbatim of events too weak to drive/blew up my energy/ no energy, can't go down her basement because her knees (right) don't bend/can't go down steps, she had swelling above knee down to ankle/leg was swollen triple size updated. Clinical course updated. Text amended accordingly.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
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 Key10122163
MDR Text Key201675094
Report Number2246315-2020-00067
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial
Report Date 05/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
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 Treatment Data
Date Received: 06/05/2020 Patient Sequence Number: 1
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