• 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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2020
Event Type  Injury  
Event Description
Must use a walker because she is very handicapped after [walker user]. Pain for 2-3 days after the injection but the recovery time is getting longer and longer [pain injection site]. Patient received synvisc one injection in left hip [product administered at inappropriate site]. Case narrative: initial information received on 22-feb-2021 regarding an unsolicited valid serious case received from a patient from (b)(6). This case is cross referred with cases (b)(4) (multiple devices, same patient). This case involves a (b)(6) years old female patient who received hylan g-f 20, sodium hyaluronate (synvisc one) and must use a walker because she is very handicapped after, pain for 2-3 days after the injection but the recovery time is getting longer and longer, patient received synvisc one injection in left hip. The patient's past medical history, vaccination(s) and family history were not provided. Patient had received synvisc one previously on (b)(6) 2020 in left hip. On (b)(6) 2020, the patient received hylan g-f 20, sodium hyaluronate injection (second injection), at a dose of 6 ml, once (route and lot - unknown) in left hip (product administered at inappropriate site) for osteoarthritis of the hip. Information on batch number was requested. On the same day, patient only experienced pain for 2-3 days after the injection but the recovery time was getting longer and longer (injection site pain). There was no inflammation, but patient must use a walker because she was very handicapped after (walking aid user, onset date: 2020 and latency: unknown). Patient felt wonderful once she recovered. Patient wanted to know if this was normal, difference between synvisc and synvisc-one, how long were they supposed to last and what was the average recovery time. First time product used: no, still using product: no, was device used : yes. Action taken: not applicable for all events. It was not reported if the patient received a corrective treatment for all events. Outcome: recovered for injection site pain and walking aid user, not applicable for other event. Seriousness criteria: disability for walking aid user. A product technical complaint was initiated with results pending for the same.
 
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 Key11385999
MDR Text Key243349724
Report Number2246315-2021-00078
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 03/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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: 02/26/2021 Patient Sequence Number: 1
-
-