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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 7RSL021
Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Vertigo (2134); Dizziness (2194); Arthralgia (2355); Joint Swelling (2356); Numbness (2415); No Code Available (3191)
Event Date 12/12/2017
Event Type  Injury  
Event Description
Ambulating with walker [walking aid user]. Numbness in right leg [numbness in leg]. Pain in left leg [pain]. Pain in knee as well as above and below [knee pain] ([condition worsened]). Swelling [knee swelling] ([condition worsened]). Case narrative: this case is cross referenced with case (b)(4) (same patient). Initial information received on 13-sep-2018 regarding an unsolicited valid serious case from united states received from a healthcare professional. This case involves a (b)(6) years old female patient who was ambulating with walked, had numbness in right leg, pain in left leg, experienced pain in knee as well as above and below, increased swelling, with the use of hylan g-f 20, sodium hyaluronate (synvisc one). The patient's past medical history included tobacco user, thyroid disorder, tonsillectomy, drug hypersensitivity with sulfa antibiotics, constipation, dyspepsia, insomnia, sinusitis, peripheral swelling, arthralgia, pain in extremity, back pain, surgery, arthroscopic knee surgery , arthroscopy and a reaction to synvisc on her last attempt to use this. The patient's past medical treatment included steroid injection in left knee. On (b)(6) 2014 mri reports revealed degenerative disc disease of most of her lumbar spine with some central canal stenosis and left foraminal stenosis at l4-l5; degenerative arthritis of her left knee. On (b)(6) 2016, x-ray reports revealed sclerotic cystic area note din the medial tibia and is degenerative in nature. The patient's family history included arthritis to father and brother, heart attack to father, heart disorder to father, high blood pressure in father, mother and sister, dementia in mother and sister, stroke in mother, diabetes mellitus in brother, gout in brother, cancer and thyroid problem in sister. The patient's past vaccination(s) was not provided. Concomitant medications included meloxicam (mobic); estradiol, norethisterone acetate (activella); diclofenac potassium (cataflam) ; levothyroxine ,trazodone, depo-medrol, cyclobenzaprine. On (b)(6) 2017, the patient was administered synvisc one (hylan g-f 20, sodium hyaluronate)injection 6 ml 1x intra-articular (with an unknown batch number) for degenerative arthritis and pain of left knee. The pain was primarily medial and was more in the full extension of the knee. She has 0 to 130 degree of motion. Treatment options were discussed. After the sterile prep the left knee was injected with 6 cc of synvisc one. Patient tolerated this well. On (b)(6) 2017, patient reported of increased pain in knee as well as above and below, increased swelling , ambulating with walker. Patient denied fever. On (b)(6) 2017, patient confirmed swelling and pain had improved, patient was informed that synvisc batch was contaminated. On (b)(6) 2018, patient had returned for steroid injection in her left knee. She stated that her knee was not bothering her but since she was leaving for her trip on saturday and would be doing a lot of walking. After sterile prep the left knee was injected with 40 mg of depo-medrol and 2 cc of 1%lidocaine. Patient tolerated this well, she would continue non impact exercising. Patient had been doing some swimming and was recommended to continue. On an unknown date in 2018, it was reported that patient could walk up the stairs, burning had improved and reaction resolved and 1 month relief from synvisc. She reported that she had numbness in right leg and pain in left leg and that mobic had helped her. Outcome : recovering / resolving for pain in knee as well as above and below, swelling, as unknown for ambulating with walker; unknown for numbness in right leg and pain in left leg. Seriousness criteria: disability for ambulatory with walker.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer Contact
darlene kadel
55 corporate drive, ms 55b-220
a
bridgewater, NJ 08807
MDR Report Key7916402
MDR Text Key122001747
Report Number2246315-2018-00586
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
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 02/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/01/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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: 09/27/2018 Patient Sequence Number: 1
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