• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number 7RSL013
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Erythema (1840); Fatigue (1849); Arthralgia (2355); Joint Swelling (2356); Confusion/ Disorientation (2553); No Code Available (3191)
Event Date 12/26/2017
Event Type  Injury  
Event Description
Pseudosepsis/ pseudoseptic infection [pseudosepsis] ([injection site allergic reaction], [aching (l) knee], [swelling of l knee], [joint effusion], [injection site joint erythema]), limited range of motion/mobility affected [joint range of motion decreased], leg was three times its normal size [unilateral leg swelling], immune deficiencies [immune system disorder], trouble sleeping [difficulty sleeping], sinus pain [sinus pain], snoring [snoring], shortness of breath/difficulty breathing/short of breath doing certain tasks [shortness of breath], bruise easily [bruise], anxiety [anxiety], heartburn [heartburn], urinary urgency and gets up at night to urinate [urinary urgency], difficulty climbing stairs [movement disorder nos], changes in hair [hair texture abnormal], low grade temperature [fever], does feel unsteady on their feet [gait unsteady], weakness or fatigue [fatigue], weakness or fatigue [weakness]. Case narrative: this case is cross referred with cases (b)(4) (same patient). Initial information received from united states on 05-aug-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case involves a 56 years old female patient who started treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and experienced after few months, patient had pseudosepsis/pseudoseptic infection, leg was three times its normal size, limited range of motion/mobility affected, weakness or fatigue, immune deficiencies, trouble sleeping, sinus pain, snoring, shortness of breath/difficulty breathing/short of breath doing certain tasks, bruise easily, anxiety, heartburn, urinary urgency and gets up at night to urinate, difficulty climbing stairs, does feel unsteady on their feet, changes in hair and low grade temperature. The patient's past medical history included aneurysm of the ascending aorta, anxiety, echo aortic valve bicuspid, gastro oesophageal reflux disease, mixed connective tissue disease, thyroid disease, internal derangement of knee, palpitations, raynaud's phenomenon, hysterectomy, thyroid surgery sub total thyroidectomy, low blood pressure, back pain, pneumonia, heat intolerance, non-smoker, left ankle pain/right ankle pain , chest pain, palpitations, leg swelling, lightheadedness, social drinker, stress fracture, right foot pain, likely foci of degenerative/bony stress reactive changes in right greater than left posterior inferior calcaneus, left greater than right anterior talus, right first and left fifth metatarsophalangeal joint, and left first interphalangeal joint, drug allergy with sulfa drugs and cedax caps. Patient had ongoing chronic primary osteoarthritis of left and right knee and left and right knee pain. The patient's family history included diabetes mellitus with mother, father and cardiac disorder/heart disease with mother, father and breast cancer with age during first menstrual period: 11. Concomitant medications included atenolol (atenolol); flecainide acetate (flecainide acetate); folic acid (folic acid); hydroxychloroquine sulfate (plaquenil); omeprazole (prilosec); levothyroxine sodium (synthroid); torsemide (torsemide); and rivaroxaban (xarelto). The patient's past medical treatment(s), vaccination(s) was not provided. On (b)(6) 2017, the patient received intra-articular hylan g-f 20, sodium hyaluronate injection in left knee, formulation injection, once dosage unknown intra-articular (lot - 7rsl013, expiry apr-2020)) for osteoarthritis of left knee. On 26-dec-2017, after few days of latency, patient had above normal swelling in left knee causing limited range of motion. On and unknown date, after unknown latency allergy injection reaction to synvisc one, weakness or fatigue, immune deficiencies, trouble sleeping, sinus pain, snoring, bruise easily, anxiety, heartburn, urinary urgency and gets up at night to urinate, difficulty climbing stairs, does feel unsteady on their feet, changes in hair, shortness of breath/difficulty breathing and short of breath doing certain tasks pain and erythema. It was reported that swelling/effusion and increased pain was most likely a pseudosepsis from injection. Patient's mobility was affected, and she had a low -grade temperature. She also developed fluid in her left knee which needed to be aspirated. By, (b)(6) 2018, patient's leg was three times its normal size. It was also reported that, photos were taken, and it was snow storms that week, so it was difficult to get out and travel. Patient was told he received contaminated injection and had a pseudoseptic infection. Patient was elevating her knee, applying ice. Patient had left knee aspirated and injected with steroid which she noted moderate improvement and better function. It was further reported that, examination of the left knee demonstrated no visible abnormalities. No tenderness. Rom examination of the left knee demonstrated full range of motion and 5/5 motor strength in all directions. Special test of the left knee revealed a negative anterior drawer sign, a negative posterior drawer sign, stable to valgus stress at 30 degrees flexion and stable to various stress at 30 degrees flexion. Action taken: not applicable. Corrective treatment: depo-medrol, ice, elevation, ibuprofen for pseudosepsis/ pseudoseptic infection; not reported for rest all events. Outcome: unknown for all the events.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8892435
MDR Text Key155492846
Report Number2246315-2019-00213
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 consumer
Type of Report Initial,Followup
Report Date 09/02/2019
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 Expiration Date04/01/2020
Device Lot Number7RSL013
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
-
-