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


  • 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

Lot Number BRSL011
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Anxiety (2328); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/26/2021
Event Type  Injury  
Event Description
Likely allergic to it/allergic reaction [device allergy] ([joint stiffness], [injection site itching], [swelling of l knee], [aching (l) knee], [joint range of motion decreased], [joint warmth], [joint inflammation], [effusion (l) knee], [arthrocentesis]), pain was shooting [shooting pain], very anxious [anxiety], couldn't sleep [difficulty sleeping]. Case narrative: initial information received on 06-aug-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp from (b)(6). This case involves a (b)(6) female patient who was likely allergic to it/allergic reaction, pain was shooting, very anxious and couldn't sleep with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. In (b)(6) 2021, the patient received treatment with hylan g-f 20, sodium hyaluronate injection (dose, frequency, route unknown) ( batch number: brsl011, expiry date- 29-feb-2024)) for left knee arthritis in left knee. Specialist said for couple weeks it would be sore but then it would improve. On (b)(6) 2021, after latency of approx. Few days, it went ballistic (joint swelling), it went to stiff (joint stiffness), she could not bend or straighten it (joint range of motion decreased). Specialist said she was likely allergic to it (device allergy), it was quite itchy, and when he took the fluid out that spot was very itchy (injection site pruritus) and painful (arthralgia). Patient further reported an allergic/inflammatory reaction (arthritis) two-three weeks following the synvisc-one injection as she had pain, stiffness, swelling and heat (joint warmth). On (b)(6) 2021, she went to emergency for 5 hours, they did x-rays and such and saw the specialist on the (b)(6) 2021, drained all the fluid out (joint effusion and aspiration joint) and he was sending it to see if it was infected and being examined for pathogens, therefore she was currently awaiting follow up with him for this. Last night on (b)(6) 2021, after latency of approx. 1 month, pain was shooting (pain) so much that she could not sleep (insomnia). Doctor gave pain relievers but nothing helped and she was very anxious (anxiety). Patient was asking if it was possible to get a refund. Action taken: not applicable for all events. Corrective treatment: pain relievers for pain; not reported for rest events. At time of reporting, the outcome was unknown for all events. Seriousness criteria: medically significant and intervention required for device allergy.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceMOZ
Manufacturer (Section D)
1125 pleasantview terrace
ridgefield 07657
MDR Report Key12310595
MDR Text Key282226183
Report Number2246315-2021-00138
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
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberBRSL011
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: 08/11/2021 Patient Sequence Number: 1