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

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.

• Brand Name: GEL-ONE CROSS-LINKED HYALURONATE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION, TAKAHAGI PLANT
• MDR Report Key: 12496396
• MDR Text Key: 272660389
• Report Number: MW5104064
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: NOT ON INSERT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 58