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

Model Number 00-1111-001-00

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problem Autoimmune Reaction (1733)

Event Date 08/11/2019

Event Type  Injury  

Manufacturer Narrative

This case was received by seikagaku corporation on november 6, 2019 from the fda as mw5090541 dated october 29, 2019.We attempt to contact the reporter through our us partner.

Event Description

2019-unk - a patient had gel-one injection in the right knee for osteoarthritis.The patient felt fine, injection site was slightly sore.2019-unk - the patient began feeling achy (flu like).The patient had a fever and a red rash going down the right leg.2019-unk - the patient was hospitalized with a 103 degrees [fahrenheit] fever, the rash moving from the right leg to the abdomen, right and left buttocks and left leg to the knee.Rash was very very painful and spreading more each day.The patient spent 6 days in the hospital.2019-unk - infectious disease specialists tested for all types of tick borne illnesses and those were negative.Many biopsies also."sweet syndrome" was the final diagnosis.Autoimmune reaction to the gel-one injection.

Manufacturer Narrative

This is a definitive report.H6 and h10 were updated.According to our us partner on march 3, 2020, no additional information was available in contact attempts on november 21, february 19 and march 3 to the reporter.This case was received by seikagaku corporation on november 6, 2019 from the fda as mw5090541 dated october 29, 2019.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

2019-unk - a patient had gel-one injection in the right knee for osteoarthritis.The patient felt fine, injection site was slightly sore.2019-unk - the patient began feeling achy (flu like).The patient had a fever and a red rash going down the right leg.2019-unk - the patient was hospitalized with a 103 degrees [fahrenheit] fever, the rash moving from the right leg to the abdomen, right and left buttocks and left leg to the knee.Rash was very very painful and spreading more each day.The patient spent 6 days in the hospital.2019-unk - infectious disease specialists tested for all types of tick borne illnesses and those were negative.Many biopsies also."sweet syndrome" was the final diagnosis.Autoimmune reaction to the gel-one injection.

• 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: 9397160
• MDR Text Key: 168776369
• Report Number: 9612392-2019-00018
• 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: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• 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: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CALCIUM.; CALCIUM.; MAGNESIUM.; MAGNESIUM.; PROBIOTIC.; PROBIOTIC.; VITAMIN B12.; VITAMIN B12.
• Patient Outcome(s): Hospitalization; Other