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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 Urinary Tract Infection (2120); Fungal Infection (2419); Respiratory Tract Infection (2420); No Code Available (3191)
Event Date 11/01/2017
Event Type  Injury  
Event Description
Device malfunction [device malfunction], had an infection in her left knee in 11/17 after a synvisc injection/knee infection after knee injection [arthritis infective] ([aching (l) knee], [swelling of l knee], [joint effusion]) uti/uti with burning/urine culture positive for e. Coli [urinary tract infection enterococcal] ([urinary frequency], [burning micturition], [cloudy urine], [nitrite urine present], [urine leukocyte esterase positive], [bacteria urine identified], [white blood cells urine increased], [gram-positive bacterial infection]), acute upper respiratory infection [upper respiratory infection] ([influenza a virus infection], [fever], [chills], [cough], [nasal congestion], [fatigue], [general malaise]), some petechiae on her arms and chest [petechiae], scab noted in left external ear canal [scab], nausea [nausea], diarrhea [diarrhea], her left ear was bleeding [ear haemorrhage], perineal yeast infection/yeast dermatitis [yeast infection of the skin], patellofemoral crepitus [crepitations], white blood cell count decreased [white blood cell count decreased], monocyte percentage increased [monocyte percentage increased], urea nitrogen decreased [urea nitrogen increased], absolute lymphocytes decreased [lymphocyte count decreased], absolute eosinophil decreased [eosinophil count decreased], urine ketone present 1+ [urine ketone body present], had pain in all her joints/complaining of pain in her joints [joint pain]. Case narrative: initial information received on 05-aug-2019 regarding an unsolicited valid non-serious legal case received from lawyer from united states. This case involves a 38 years old female patient (167. 6 cm and 73 kg) who experienced had an infection in her left knee in 11/17 after a synvisc injection/knee infection after knee injection (latency: few days), acute upper respiratory infection (latency: few months), some petechiae on her arms and chest, scab noted in left external ear canal, nausea, diarrhea (latency: few months), her left ear was bleeding (latency: 2 months 22 days), uti/uti with burning/urine culture positive for e. Coli (latency: unknown), perineal yeast infection/yeast dermatitis, patellofemoral crepitus (latency: unknown), white blood cell count decreased (latency: 4 months 13 days), monocyte percentage increased (latency: 5 months 18 days), urea nitrogen decreased, absolute lymphocytes decreased, absolute eosinophil decreased (latency: 4 months 13 days), urine ketone present 1+ (latency: 12 days)and had pain in all her joints/complaining of pain in her joints (latency: few days), while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one). A device malfunction was noted in the reported batch number. The patient's past medical history included gastric bypass, cerebrospinal fluid rhinorrhea through the left nostril, anemia with undergoing iv infusions at present, intra-pregnancy internal hernia requiring repair, prematurity of birth and had 5 pregnancies and 3 live births all of them premature, lumbar puncture (lp), dizziness, headache, 5 pregnancies, 3 live births, frequent 2 miscarriages- one at 24 weeks, undergone nerve blocks, pain/7/10 aching pain/10/10 pain, minor abdominal pain underneath her right costal margin, vitamin d deficiency, abdominal surgery, uterine uplift, wisdom tooth removal, left leg pain, mild scoliosis, minimal disc bulging/minimal broad-based central disc protrusion, non-traumatic left hip pain, pain related insomnia, left hip numbness, left hip weakness, diffuse lower lumbar paraspinal tenderness, guarded decreased lumbar flexion, straight leg raise positive for left posterior hip pain only, facet loading positive on the left, patellar tendon reflex 1+, worsening pain in left knee/anterior or posterior knee pain, functional limitations of adl's, patellofemoral degenerative arthrosis, small popliteal fossa cyst and ganglia along both the medial, lumbago, lumbar degenerative disc disease, mild l4-5 disc bulge/annual tear and lateral aspect of the knee posteriorly. The patient's family history included diabetes, hypertension, coronary artery disease, rheumatoid arthritis (ra; both grandmothers), myocardial infarction and digestive disorder. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing ich/inter-cranial hypertension formerly known as pseudotumor cerebri, morbid obesity, neuropathic type symptoms that radiate down her leg, chronic fatigue, sleep apnoea, low back pain/back pain/non-traumatic back pain and hypertensive disorder, systemic arterial. Patient is a current every day smoker with 0. 5 pack/day of cigarettes for 10 years (never used smokeless tobacco) and is a alcohol user. Concomitant medications included calcium citrate; norethisterone (camila); cyanocobalamin; ergocalcifero; vitamins nos (multivitamins); venlafaxine hydrochloride (effexor); cyanocobalamin (vitamin b12); azithromycin (azithromax); methylprednisolone (medrol); hydrocodone bitartrate, paracetamol (norco) for pain; gabapentin (neurontin); vitamin d nos; tocopherol (vitamin e); atenolol; cyclobenzaprine; hydrocodone bitartrate, paracetamol (hycet) for pain; oxycodone hydrochloride, paracetamol (percocet); prednisone; chlorzoxazone, paracetamol (skelaxine) for muscle spasms; and meloxicam (mobic) and tramadol. On (b)(6) 2019, patient presented with she is having persistent pain. But had full extension, 140 degrees of flexion. Patient had a lot of patellofemoral crepitus. On (b)(6) 2019, the patient received hylan g-f 20, sodium hyaluronate injection via intra-articular route at an unknown dosage once (lot- 7rsl021, may 2020) for oa of left knee. Patient was asked for follow-up after 3 weeks, if not markedly better. On the same day, patient was feeling better and was prescribed meloxicam. On (b)(6) 2019, patient reported to have increased pain last night with flexion and had a lot of swelling since the injection and had a large effusion. The doctors reported on the same day, that the lot they injected her with that several other doctors had an increase of flare but there was no evidence of contamination or other problems other than the increased flare. On the same day, doctors aspirated patient knee and got 40 ml of cloudy fluid and sent it for gram stain, fungal cultures, anaerobic cultures, protein, glucose, and cell count. On (b)(6) 2017, after 1 day, the synovial fluid which was tested showed rare epithelial cells and few white blood cells in the body fluid. On (b)(6) 2017, patient was aspirated and 15 ml of fluid was drawn which was sent it for cell count with differential, gram stain, and c&s. On (b)(6) 2019, after 6 days, the chemistry of synovial fluid showed no epithelial cells, few white blood cells and rare gram-positive rods. No fungal elements were seen. On (b)(6) 2017, patient returned for follow-up on her knee. Doctors got a notice yesterday that they recalled the lot with her hylan g-f 20, sodium hyaluronate injection and there was concern about possible gram-negative infection. Patient still had a lot of patellofemoral crepitus. Patient had no effusion; no erythema or warmth. Doctors were going to watch it closely for any increased pain or swelling; otherwise, would see her back in 2 weeks and in case of any doubt would consider aspirating. On an unknown date in (b)(6) 2017, after few days, patient had pain in all her joints. On (b)(6) 2017 at 10:32 hours, lab tests revealed cloudy urine (abnormal; ref: clear), urine ketone present 1+ (abnormal; ref: negative), urine nitrite present (abnormal; ref: negative), urine leukocyte esterase (positive; ref: negative), bacteria urine few (abnormal; ref: none seen/hpf), wbc urine >
=
60/hpf (high; ref: <
=
5/hpf). As of an unknown date in (b)(6) 2017, patient was concerned that she might have a uti with burning, frequency and thought that she had a perineal yeast infection. On (b)(6) 2017, urine culture was found to be positive for e. Coli. On (b)(6) 2018, after 2 months 22 days, patient had left ear bleeding and woke up to blood on her pillow. Patient had some petechiae on her arms and chest, scab noted in left external ear canal. On (b)(6) 2018 at 11:57 pm, test for influenza a virus positive. On an unknown date in 2018, patient visited hospital with fever that has reached 101, chills, cough, nasal congestion, nausea, and diarrhea for 5 days. On an unknown date in 2018, patient took otc theraflu without much relief. On (b)(6) 2018 at 11:03 am, lab tests revealed urea nitrogen 6 mg/dl (low; ref: 7-25), white blood cell count 3. 2 thousand/ul (low; ref: 3. 8-10. 8), absolute lymphocytes 733 cells/ul (low; ref: 850-3900), absolute eosinophils 0 cells /ul (low; ref: 15-500). On (b)(6) 2018 at 04:27 pm, lab tests revealed white blood cell count 4. 2 k/cmm (low; ref: 4. 5-11), monocyte percentage 11% (high; ref: <
=
10%). Final diagnosis was had pain in all her joints/complaining of pain in her joints, had an infection in her left knee in 11/17 after a synvisc injection/knee infection after knee injection, urine ketone present 1+, her left ear was bleeding, absolute eosinophil decreased, absolute lymphocytes decreased, urea nitrogen decreased, white blood cell count decreased, monocyte percentage increased, diarrhea, nausea, scab noted in left external ear canal, some petechiae on her arms and chest, acute upper respiratory infection, patellofemoral crepitus, perineal yeast infection/yeast dermatitis, uti/uti with burning/urine culture positive for e. Coli. Corrective treatment: rest, hydration, handwashing recommended for flu/positive for flu type a; chlorphenamine maleate, paracetamol, pseudoephedrine hydrochloride (theraflu) for fever that has reached 101; brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride (bromphed) and azithromycin (z-pak) for cough; ciprofloxacin hcl for suspected uti/uti with burning; fluconazole (diflucan) for perineal yeast infection/yeast dermatitis and methylprednisolone (medrol) for had an infection in her left knee in 11/17 after a synvisc injection. Outcome: recovered/resolved for flu/positive for flu type a, fever that has reached 101, chills, cough, nasal congestion, nausea, diarrhea; not recovered/not resolved for had persistent fatigue/chronic fatigue, general malaise, white blood cell count decreased; recovering for persistant pain/ pain increased last night/pain with flexion/increased pain since the injection/started flaring on her and a lot of swelling/swelling in her left knee since the injection/started flaring on her; unknown for rest all events. The product technical complaint (ptc) was initiated and the results were pending for the same.
 
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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 Key8892434
MDR Text Key155214825
Report Number2246315-2019-00210
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,Followup
Report Date 08/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2019
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: 08/14/2019 Patient Sequence Number: 1
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