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

Model Number	00-1111-001-00
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	10/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case is received by seikagaku corporation on december 3, 2019 from the fda as mw5091186 dated (b)(6) 2019.According to the result of investigation, there were no deviations or out-of-specifications found in the manufacturing process, the in-process testing, the release testing, and the environmental monitoring for lot# 0019g08g.We attempt to contact the reporter through our us partner.
Event or Problem Description
On (b)(6) 2019 - a patient received gel-one injection in the knee at the patient's rheumatologist.This was the third injection in 2 years.The doctor first cleaned the area with alcohol and then she sprayed a topical numbing spray (gebaurer ethyl chloride).The doctor then injected the gel-one in the knee.The doctor asked the patient several times if the patient was ok since it was harder for the medicine to be injected this time.After the full injection was administered, the patient started feeling lightheaded, seeing stars and was really faint and then the throat started feeling weird, the patient started wheezing and having a problem breathing.The pulse was very low.The doctor called 911 she administered benadryl by injection and also, a steroid by injection and nothing was helping so they ended up using the patient's epi-pen (the patient is allergic to bees).The patient was stable and then taken to a healthcare facility for observation.The patient saw an allergist.
Event or Problem Description
(b)(6) 2019- a patient received gel-one injection in the knee at the patient's rheumatologist.This was the third injection in 2 years.The doctor first cleaned the area with alcohol and then she sprayed a topical numbing spray (gebaurer ethyl chloride).The doctor then injected the gel-one in the knee.The doctor asked the patient several times if the patient was ok since it was harder for the medicine to be injected this time.After the full injection was administered, the patient started feeling lightheaded, seeing stars and was really faint and then the throat started feeling weird, the patient started wheezing and having a problem breathing.The pulse was very low.The doctor called 911 she administered benadryl by injection and also, a steroid by injection and nothing was helping so they ended up using the patient's epi-pen (the patient is allergic to bees).The patient was stable and then taken to a healthcare facility for observation.The patient saw an allergist.
Additional Manufacturer Narrative
This is a definitive report.H10 was updated.According to our us partner on january 14, 2020, no additional information was available in contact attempts on december 16, january 3 and 9 to the reporter.This case is received by seikagaku corporation on december 3, 2019 from the fda as mw5091186 dated november 26, 2019.According to the result of investigation, there were no deviations or out-of-specifications found in the manufacturing process, the in-process testing, the release testing, and the environmental monitoring for lot# 0019g08g.

• Brand Name: GEL-ONE
• Common Device Name: 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: 9503583
• Report Number: 9612392-2019-00020
• Device Sequence Number: 19578395
• Product Code: MOZ
• UDI-Device Identifier: 00087541300912
• UDI-Public: (01)00087541300912(17)200825(10)0019G08G(422)392
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P080020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/25/2020
• Device Model Number: 00-1111-001-00
• Device Catalogue Number: 00-1111-001-00
• Device Lot Number: 0019G08G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELAVIL; ELAVIL; HYDROCHLOROTHIAZIDE; HYDROCHLOROTHIAZIDE; IMEVEXXY; IMEVEXXY; IRON; IRON; LIPITOR; LIPITOR; LOSARTAN; LOSARTAN; NEXIUM; NEXIUM; PLAQUENIL; PLAQUENIL; VIT D; VIT D; VITAMIN B12; VITAMIN B12; XYZAL; XYZAL
• Outcome Attributed to Adverse Event: Life Threatening