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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 Problem Microbial Contamination of Device (2303)
Patient Problems Anemia (1706); Glaucoma (1875); Pain (1994); Thyroid Problems (2102); Weakness (2145); Chills (2191); Arthralgia (2355); Joint Swelling (2356); Respiratory Tract Infection (2420); No Code Available (3191)
Event Date 07/12/2018
Event Type  malfunction  
Event Description
Device malfunction: open angle glaucoma, suspected low risk bilateral/borderline glaucoma with ocular hypertension, bilateral. Neoplasm of uncertain behavior of skin/acrochordon. Elevated t4. Elevated tsh. Iron deficiency anemia. Chest tightness. Polydipsia. Pain localized to the general lower extremity. Watery eyes. Poor appetite. Body aches. Viral uri with cough, unspecified [viral upper respiratory tract infection] ([sinus pain], [sore throat], [productive cough], [mucus discharge]). Worsened/aggravated constantly, with normal activities, in bed, bending, using stairs, rising from a chair at higher levels of activity [pain upon movement]. Weakness. Chills. Trouble walking distances/limping. Effusion right knee 1+. Some pain/localized to medial, lateral, anterior and posterior knee/joint painful, described pain as aching, cramping, radiating and sharp [knee pain] ([condition aggravated], [subtherapeutic response]). Some swelling [swelling of r knee] ([condition aggravated]). Case narrative: this case was cross referenced with case (b)(4) (same patient). Initial information received from united states on 19-feb-2019 regarding an unsolicited valid serious legal case received from a lawyer. This case involves a (b)(6) female patient who had open angle glaucoma, suspected low risk bilateral/borderline glaucoma with ocular hypertension, bilateral (latency: 7 months 3 days), neoplasm of uncertain behavior of skin/acrochordon (latency: 2 months 21 days), elevated tsh, elevated t4 (latency: 6 months 22 days), iron deficiency anemia (latency: 5 months 10 days), viral uri with cough, unspecified (latency: 7 months 10 days), chest tightness, polydipsia, pain localized to the general lower extremity, watery eyes, poor appetite, body aches, weakness, chills, trouble walking distances/limping, some swelling, effusion right knee 1+, aggravated constantly, with normal activities, in bed, bending, using stairs, rising from a chair at higher levels of activity (latency: unknown), some pain/localized to medial, lateral, anterior and posterior knee/joint painful, described pain as aching, cramping, radiating and sharp (latency: 0 day), after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one). A device malfunction was noted in the reported batch number. Medical history included extraction teeth on 1980, knee injury in 1985, cholecystectomy in 1986, smoker until (b)(6) 2011 (duration: 5 years), influenza immunization (tiv (im) on (b)(6) 2012 and (b)(6) 2013, iiv3, im pres free on (b)(6) 2014, iiv4, im pres free on (b)(6) 2016), upper gastrointestinal endoscopy on (b)(6) 2013, hepatitis a immunization on (b)(6) 2016, achilles tendon repair in 2013 and (b)(6) 2014, cesarean section twice, excision partial talus/calcaneus, intraoperative fluoroscopy on (b)(6) 2014, limited strength, limited range of motion, impaired gait, chronic bilateral knee pain, limited muscular endurance since (b)(6) 2017, hysteroscopy, endometrium (curettage) on (b)(6) 2017, adenoid surgery, synvisc for osteoarthritis knee (administered 8-9 months before (b)(6) 2017: reduced the pain), knee arthroscopy, abdominal pain, arthritis, dyspareunia, fatigue, tubal ligation, visual disturbance, nausea, frequency, numbness, hematuria, tiredness with difficulty falling back to sleep, periodic limb movement disorder, acute cystitis without hematuria. Family history included alcohol abuse (son), alzheimer's disease, arthritis (father, mother), brain cancer (maternal grandmother), colon cancer (paternal grandmother), depression (brother, mother, son), diabetes, glaucoma (mother), heart disease (mother), high blood pressure: hypertension (mother, father), hyperlipidemia: elevated cholesterol (mother), leukemia (paternal grandfather), myocardial infarction: heart attack (mother), osteoarthritis (father), osteoporosis: thinning of bones (father). Patient had ongoing chronic essential hypertension, chronic depression, chronic polycystic ovarian syndrome (irregular menses, hirsutism, hyperglycemia, possible endometriosis hx, dysmenorrhea, provera use leads to vulvar furuncles), chronic mixed headache syndrome, irritable bowel syndrome since (b)(6) 2012, stress incontinence, chronic furuncles since (b)(6) 2012, chronic cough since (b)(6) 2012, calcaneal spur since (b)(6) 2013, chronic hiccoughs since (b)(6) 2013, generalized anxiety disorder, unspecified anxiety since (b)(6) 2013, equinus deformity of foot, acquired since (b)(6) 2013, haglund's deformity since (b)(6) 2013, dysphagia since (b)(6) 2013, morbid obesity since (b)(6) 2013, tachycardia since (b)(6) 2014, chronic fatty liver disease, nonalcoholic since (b)(6) 2014, restless legs syndrome since (b)(6) 2014, chronic back pain since (b)(6) 2014, blurry vision (endorses worsening blurry distance vision), chronic allergic rhinitis due to pollen, chronic muscle spasms of lower extremity since (b)(6) 2015, primary osteoarthritis of both knees since (b)(6) 2016, snoring since (b)(6) 2017, achilles tendinitis (right leg contracture, intermittent ankle edema), since (b)(6) 2017, plantar fascitis, right since (b)(6) 2017, hypersomnia since (b)(6) 2017, gastroesophageal reflux disease, depression, unspecified, occupational disabled, hepatic steatosis, blood sugar increased/hyperglycemia (once around 200), ace inhibitors and zofran allergy (cough due to ace inhibitors, itching with zofran), uncontrolled diabetes mellitus type ii without complication, abscesses in pannus of abdomen, hidradenitis suppurativa vs recurrent mrsa furunculosis, idiopathic peripheral neuropathy (worse in feet, extends to knees worsening over past one and half year), bilateral carpal tunnel syndrome and had surgery for the same, recurrent sneezing, congestion and rhinorrhea, hepatomegaly, diarrhea and constipation due to alternating bowel habits, recurrent numbness and light headedness, mild sensory polyneuropathy. Concomitant medications included paracetamol (tylenol extra-strength); dicycloverin hydrochloride (bentyl); plantago ovata (metamucil); sulfamethoxazole, trimethoprim (bactrim ds); amlodipine besilate (norvasc); bupropion hydrochloride (wellbutrin); buspirone hydrochloride (buspar) for anxiety; celecoxib (celebrex); cetirizine hydrochloride (zyrtec); chlorhexidine gluconate (hibiclens); chlorthalidone; clindamycin phosphate (cleocin t); clonazepam (klonopin) for anxiety; diclofenac sodium (voltaren); esomeprazole sodium (nexium); mometasone furoate (flonase); gabapentin (neurontin); hydrocortisone; losartan potassium (cozaar); metformin hydrochloride (glucophage); potassium chloride (klor-con); pramipexole dihydrochloride (mirapex); and vortioxetine. On (b)(6) 2017, the patient started using hylan g-f 20, sodium hyaluronate, intra-articular injection at the dose of 6 ml, once (lot - 7rsl021) for osteoarthritis of right knee. It was reported that complete relief for 1 hour but then worsening pain (latency: 0 day). Patient had some pain and within first week of injection had swelling which improved slightly but had since worsened. Patient stated that the pain was similar now to what it was before the injection. When joint was painful, patient described as aching, cramping, radiating and sharp marked (major pain with significant limitations) pain. Symptoms have been present for 1 month and has moderately worsened since their previous visit. Pain was aggravated constantly, with normal activities, in bed, bending, using stairs, rising from a chair, at higher levels of activity and without relationship to any activity. Pain is localized to the general lower extremity, medial knee, lateral knee, anterior knee and posterior knee. The patient had tried ice and rest to help with the pain. She has tried celecoxib, ibuprofen, meloxicam (mobic), naproxen, diclofenac sodium and cefixime (flexeril) with no change. Pain was relieved by nothing adequately tried by patient. Patient stated that she received her letter stating a recall of her hylan g-f 20, sodium hyaluronate injection, but she has not had any symptoms described other than continued pain. Patient denies any fevers, nausea, vomiting, or erythematous joint and stated that her swelling had improved. Patient had moderate limping, effusion of 1+ on (b)(6) 2017. On (b)(6) 2018, neoplasm of uncertain kind was noted on right upper thigh and had shave biopsy which showed acrochordon (latency: 2 months 21 days). Patient had trouble walking distances because of the knees and complained of polydipsia (latency: unknown). On (b)(6) 2018, patient was diagnosed with iron deficiency anemia (latency: 5 months 10 days). On (b)(6) 2018, patient had elevated tsh and t4 (latency: 6 months 22 days). She has increased pain with increased activity. She must use a scooter at the store as she cannot tolerate walking the distance needed to run her errands. On (b)(6) 2018, patient presented with suspected bilateral open angle glaucoma, low risk, diagnosed with borderline glaucoma with ocular hypertension, bilateral (latency: 7 months 3 days). On (b)(6) 2018, patient was diagnosed with viral upper respiratory tract infection with fatigue, cough, sneezing, body aches, weakness, subjective child, poor appetite, sinus congestion, pain, yellow mucus productive cough with watery eyes and running nose (latency: 7 months 10 days). Patient was advised to have intra-articular glucocorticoid injection but could not do that due to redness and swelling in anterior tibial region which was consistent with cellulitis of left leg. By (b)(6) 2018, there was no erythema, warmth or any suggestion of skin infection. Corrective treatment: ibuprofen, codeine phosphate, guaifenesin, otc nasal saline wash for viral uri with cough, unspecified, metformin for trouble walking distances/limping, ice, naproxen, meloxicam, cefixime, ibuprofen and rest for some pain/localized to medial, lateral, anterior and posterior knee/joint painful, described pain as aching, cramping, radiating, sharp; aggravated constantly, with normal activities, in bed, bending, using stairs, rising from a chair at higher levels of activity; not reported for rest. Outcome: not recovered for iron deficiency anemia, viral uri with cough, unspecified, some pain/localized to medial, lateral, anterior and posterior knee/joint painful, described pain as aching, cramping, radiating, sharp, device malfunction; recovering for some swelling, recovered for effusion right knee 1+, unknown for rest. A product technical complaint was initiated for synvisc one with batch number 7rsl021: an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021. The product met all release testing at time of manufacture in june 2017. Retain samples were retested due to the unexpected increase in adverse events. Higher than expected endotoxin results were obtained. In addition, the presence of microbial contamination was also confirmed. The cause of these events was under investigation. Once this investigation is completed, corrective and preventive actions would be implemented. Seriousness criteria: medically significant for device malfunction, open angle glaucoma, suspected low risk bilateral/borderline glaucoma with ocular hypertension, bilateral.
 
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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
darlene kadel
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key8385791
MDR Text Key141336766
Report Number2246315-2019-00074
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Remedial Action Recall
Type of Report Initial
Report Date 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number7RSL021
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: 03/04/2019 Patient Sequence Number: 1
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