• 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 7RSL021
Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Thrombosis (2100); Weakness (2145); Hypoesthesia, Foot/Leg (2354); Arthralgia (2355); Joint Swelling (2356); Numbness (2415); No Code Available (3191)
Event Date 11/01/2017
Event Type  Injury  
Event Description
Dvt (deep vein thrombosis)/ 2 clots in lower leg [deep vein thrombosis] ; compression neuropathy [nerve compression] ([unilateral leg pain], [numbness in leg], [weakness], [paresthesia foot]); plantar fasciitis/ sharp shooting severe pain in bottom of foot/ hypersensitivity of planter surface of foot [plantar fasciitis] ; limited on daily activities [activities of daily living impaired] ; walker user [walker user]. Case narrative: initial information received on (b)(6) 2018 regarding an unsolicited valid serious case received from a physician and patient from united states. This case involves a (b)(6) male patient, who developed dvt (deep vein thrombosis)/ 2 clots in lower leg, compression neuropathy, plantar fasciitis/ sharp shooting severe pain in bottom of foot/ hypersensitivity of planter surface of foot, limited on daily activities and was a walker user (latency: unknown for all), after he was treated with hylan g-f 20, sodium hyaluronate (synvisc one). The patient's past medical history/ concurrent conditions included myalgia (due to statins), myositis, hyperlipidaemia, hypothyroidism, bronchitis, onychomycosis of toe nail, fever, acute sinusitis, snoring, back pain, leukocytosis, stress, fatigue, anxiety, rectal cancer with rectal cancer surgery (1980), appendicectomy, tonsillectomy, 5 right elbow surgeries from crushing injury, back surgery, depression, lack of physical exercise, inappropriate diet and eating habits, overweight and obesity. Patient is a former smoker (quit 22 years ago) and never drinks alcohol. The patient's father had hypertension, diabetes mellitus and alzheimer's disease. Patient's mother had hypertension, diabetes mellitus and breast cancer. Concomitant medications included levothyroxine sodium, pantoprazole sodium, citalopram hydrobromide, metoprolol tartrate,acetylsalicylic acid (aspirin), chondroitin sulfate, glucosamine hydrochloride (osteo bi-flex), cascara sagrada (rhamnus purshiana), bacopa monnieri herb, camellia sinensis leaf, curcuma longa rhizome, silybum marianum seed, withania somnifera root (protandim), gabapentin and apixaban (eliquis). On (b)(6) 2017, the patient was treated with hylan g-f 20, sodium hyaluronate injection, via intra-articular route (dose: not provided) for unknown indication. It was reported that a nerve in knee was evidently hit and 2 clots developed in the lower leg. On an unknown date of (b)(6) 2017, after unknown latency, the patient developed a serious dvt (deep vein thrombosis). This event was assessed as medically significant. Secondary to this, the patient developed a non-serious compression neuropathy, associated with left leg pain and severe pain from the knee down to the foot (pain in extremity); numbness in leg and foot (hypoaesthesia); paresthesia of foot and burning sensation in ball of left foot (paraesthesia) and weakness (asthenia). The patient developed a non-serious sharp shooting severe pain in bottom of foot and hypersensitivity of planter surface of foot (plantar fasciitis). The pain affected the left foot and ankle and was not associated with swelling. The patient's daily activities got limited and became a walker user. On (b)(6) 2017, patient reported he had return of feeling except in bottom of left foot. On (b)(6) 2018, patient was now overall better and pain was better. On (b)(6) 2018, it was reported that patient no longer had sharp, shooting pain in foot, paresthesia continued to diminish and symptoms were more of plantar fasciitis. On (b)(6) 2018, patient reported that sensation in lower leg and foot was returning but the heel was still numb. On (b)(6) 2018, patient reported significantly decreased hypersensitivity of planter surface of foot and said that rubbing bottom of foot with various surfaces had decreased the intensity of sharp pains. Final diagnosis was walker user, severe plantar fasciitis/ sharp shooting severe pain in bottom of foot/ hypersensitivity of planter surface of foot, compression neuropathy, dvt (deep vein thrombosis)/ 2 clots in lower leg and limited on daily activities. The patient was treated with gabapentin (neurontin) compression neuropathy; apixaban (eliquis) for deep vein thrombosis; gait training for being a walker user; manual therapy, whirlpool/ fluid therapy, therapeutic exercises for paresthesia of foot/ burning sensation in ball of left foot; anticoagulants (eliquis) for 3 months for dvt (deep vein thrombosis). The outcome was reported as recovering / resolving for compression neuropathy, as recovering / resolving for left leg pain/ severe pain from the knee down to the foot, as recovering / resolving for numbness in leg and foot, as unknown for weakness and for dvt (deep vein thrombosis)/ 2 clots in lower leg, as recovering / resolving for plantar fasciitis/ sharp shooting severe pain in bottom of foot/ hypersensitivity of planter surface of foot, as recovering / resolving for limited on daily activities, as recovering / resolving for paresthesia of foot/ burning sensation in ball of left foot and as recovered / resolved on an unknown date for walker user. Seriousness criteria: medically significant event of dvt (deep vein thrombosis). A product technical complaint (ptc) was initiated on 12-sep-2018 for "synvisc one". Batch number unknown, global ptc number: (b)(4). The product lot number was not provided; therefore, a batch record review was not possible. Based on the lack of information provided, no capa was required. All finished batch records for specification conformance prior to release were reviewed as per the requirement. Any out of specification result need to be identified and mitigated through the ncr process. Adverse event reports with or without lot numbers were continuously monitored by sanofi global pharmacovigilance and epidemiology and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals. Final investigation complete date was (b)(6) 2018. No safety issues were indicated in this review. Additional information was received in the form of investigation summary on 12-sep-2018. Ptc results and number was added.
 
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 NJ 07657
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater, NJ 08807
MDR Report Key8197083
MDR Text Key132355558
Report Number2246315-2018-00807
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
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 07/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2018
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: 12/26/2018 Patient Sequence Number: 1
-
-