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

Model Number 00-1111-001-00

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Anaphylactic Shock (1703)

Event Date 07/16/2019

Event Type  Injury  

Manufacturer Narrative

This is a definitive report.We found this case in fda maude site on august 15, 2019.This case is also received by seikagaku corporation on august 19, 2019 from the fda as mw5088519 dated august 13, 2019.(b)(4).The reported adverse event was described in the package insert as follows; "according to post-marketing experience of other sodium hyaluronate preparations, anaphylactic/anaphylactoid reactions accompanied by transient hypotension (sudden drop in blood pressure), have been rarely reported worldwide, all of which resolved either spontaneously or after conservative treatment.".

Event Description

On (b)(6) 2019 - thirty minutes after a gel-one injection in his right knee, the patient went to a smoke house and was told by witnesses that he turned "white".The patient then felt his throat closing and felt itching throughout his body (especially over the face and neck).The patient was then admitted into a hospital and given diphenhydramine, methylprednisolone and ranitidine.The patient's condition eventually improved.Symptoms: anaphylaxis, skin rash, urticaria pruritus.

• 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
• Manufacturer (Section G): SEIKAGAKU CORPORATION - TAKAHAGI PLANT; 258-5, aza-matsukubo; oaza-akahama; takahagi-shi, ibarki 318-0 001; JA 318-0001
• Manufacturer Contact: pharmacovigilance dept. ; marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0-005 ; JA 100-0005
• MDR Report Key: 8953942
• MDR Text Key: 161165036
• Report Number: 9612392-2019-00010
• 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: health professional
• Type of Report: Initial
• Report Date: 08/15/2019

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
• Device Operator: Health Professional
• Device Model Number: 00-1111-001-00
• Device Catalogue Number: 00-1111-001-00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening