• 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 UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/19/2020
Event Type  Injury  
Event Description
Having more trouble walking (patient walks with a walker) than before the injection [difficulty in walking] ([device ineffective], [condition aggravated]). Hyper extension in her right leg [hyperextension of knee]. The pain returned [aching (r) knee]. Case narrative: initial information received on 23-jul-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp from (b)(6). This case involves a (b)(6) years old female patient who was having more trouble walking (patient walks with a walker) than before the injection, hyper extension in her right leg and the pain returned, with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one]. The patient's past medical history included polio in 1942 (right leg was affected). The patient's past medical treatment(s), vaccination(s) and family history were not provided. On (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate injection once (lot, dose, route: unknown) for osteoarthritis knee in right knee. Patient felt some relief for the first two days after injection. On (b)(6) 2020 the patient reported that the pain returned (arthralgia), patient was having more trouble walking (patient walks with a walker) than before the injection (gait disturbance; condition aggravated) and hyper extension in her right leg (joint hyperextension) 3 days after starting use of hylan g-f 20 and sodium hyaluronate. On (b)(6) 2020 the patient reported lack of efficacy (device ineffective) 3 days after starting use of hylan g-f 20 and sodium hyaluronate. The event of gait disturbance (along with symptoms of device ineffective and condition aggravated) was leading to disability. Action taken: not applicable for all events it was not reported if the patient received a corrective treatment for the events (lack of efficacy, having more trouble walking (patient walks with a walker) than before the injection, hyper extension in her right leg, condition aggravated, the pain returned). At time of reporting, the outcome was not recovered / not resolved for all the events. A product technical complaint was initiated and the results for the same were pending.
 
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
MDR Report Key12242504
MDR Text Key282208735
Report Number2246315-2021-00131
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,foreign,health profe
Type of Report Initial,Followup,Followup
Report Date 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/28/2021 Patient Sequence Number: 1
-
-