MAUDE Adverse Event Report: SEIKAGAKU CORP. TAKAHAGI PLANT GEL-ONE; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Anaphylactic Shock (1703); Rash (2033); Skin Discoloration (2074); Urticaria (2278)

Event Date 07/16/2019

Event Type  Injury  

Event Description

Thirty minutes after a hyaluronate sodium (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 the (b)(6) and given diphenhydramine, methylprednisolone and ranitidine.Patient's condition eventually improved.Symptoms: anaphylaxis, skin rash, urticaria pruritus suspect drug #1 dosing: injected into the right knee.Treatment drug used: hyaluronate sodium dose: 30 units :mf freq: once route: other.

• Brand Name: GEL-ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORP. TAKAHAGI PLANT
• MDR Report Key: 8843038
• MDR Text Key: 153054358
• Report Number: MW5088519
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 59 YR
• Patient Weight: 132