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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEIKAGAKU CORPORATION, TAKAHAGI PLANT GEL-ONE CROSS-LINKED HYALURONATE ACID, HYALURONIC, INTRAARTICULAR

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SEIKAGAKU CORPORATION, TAKAHAGI PLANT GEL-ONE CROSS-LINKED HYALURONATE ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Lot Number NOT ON INSERT
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Itching Sensation (1943); Urticaria (2278); Swelling/ Edema (4577)
Event Date 09/14/2021
Event Type  Injury  
Event Description
Went to (b)(6) approved bilateral knee injections. Had 4 previous since 2019. Those were gelsyn: one every six months apart. On (b)(6) 2021 had appointment and was given gelone, i was told that it was same medicine but a 3 in 1. Procedure as the same, numbing spray then injection of preservative free lidocaine and then the injections. This was 11:00 a. M. And my drive home was about 25 minutes and i had begun to itch, and felt welts on face and back and right eye was beginning to swell. My husband was home and we called the emerge ortho office where i had the injections. I did not have benadryl at home and did not wish to go to the er and i did not have anaphylaxis as covid has been spiking in (b)(6) and the waiting rooms were very crowded that they were doing triage in the hallways. Husband drove me back, they took vitals: bp elevated 152/96, o2 normal, temp normal and gave me benadryl 25 mg tab. Welts were now more pronounced, and occurring all over. Wanted to jump out of my skin but knew not to scratch. They sent me to (b)(6) (hospital) urgent care, who they called ahead to expect me. The benadryl had begin to work. If not they said i would have to go to the hospital for iv benadryl. Product is distributed by (b)(4), manufactured by seikagaku corp, (b)(4). Reported the problem via phone (b)(6) 2021 to the distributor, asked that they send copy of my report to (b)(6) (my husband's email address). Not rec'd yet. Mild arthritis bilateral knees.
 
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Brand NameGEL-ONE CROSS-LINKED HYALURONATE
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
SEIKAGAKU CORPORATION, TAKAHAGI PLANT
MDR Report Key12496396
MDR Text Key272660389
Report NumberMW5104064
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberNOT ON INSERT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/17/2021 Patient Sequence Number: 1
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