MAUDE Adverse Event Report: SEIKAGAKU CORPORATION GEL-ONE; ACID, HYALURONIC, INTRAARTICULAR

Model Number 00-1111-001-00

Device Problem Insufficient Information (3190)

Patient Problems Syncope (1610); Itching Sensation (1943); Rash (2033)

Event Date 02/03/2020

Event Type  Injury  

Manufacturer Narrative

This case is received by seikagaku corporation on february 28, 2020 from the fda as mw5092945 dated february 24, 2020.We attempt to contact the reporter through our us partner.

Event Description

On (b)(6) 2020: a female patient received gel-one injection to the knee for osteoarthritis.Shortly following the injection at the md office, she fainted.She developed a severe itch and rash, and experienced chest pain.She was treated by emergency medical technicians and rushed to a hospital.On (b)(6) 2020: the patient was discharged with benadryl 50 mg.

Manufacturer Narrative

According to our us partner on may 12, 2020 no additional information was available in contact attempts on march 31, may 11.In the 2nd follow-up, the customer informed that they don't have additional information, hence the 3rd follow-up was not done.This case is received by seikagaku corporation on february 28, 2020 from the fda as mw5092945 dated february 24, 2020.We selected the code of 4316 (appropriate term/code not available) for h.6 manufacturer evaluation conclusion code, because the reported adverse event was not listed in the package insert and concerned lot number was not available.

Event Description

(b)(6) 2020 - a female patient received gel-one injection to the knee for osteoarthritis.Shortly following the injection at the md office, she fainted.She developed a severe itch and rash, and experienced chest pain.She was treated by emergency medical technicians and rushed to a hospital.(b)(6) 2020 - the patient was discharged with benadryl 50 mg.

• Brand Name: GEL-ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION; marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0 005; JA 100-0005
• MDR Report Key: 9824290
• MDR Text Key: 190516336
• Report Number: 9612392-2020-00004
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P080020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00-1111-001-00
• Device Catalogue Number: 00-1111-001-00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization