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

Lot Number 0019F07G

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Urticaria (2278)

Event Date 09/12/2019

Event Type  Injury  

Event Description

My husband was injected in both his knees with gel-one cross-linked hyaluronate.An hour later he began itching, having hives and his throat began to close.He went to the er where he was immediately taken in and given steroids and epinephrine.He is now having to take prednisone and epinephrine.He will need to go back to primary care provide as the implanted gel is in his knees for a minimum of 3 months.Zimmer distributor.Fda safety report id # (b)(4).

• Brand Name: GEL- ONE CROSS-LINKED HYALURONATE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORP., TAKAHAGI PLANT
• MDR Report Key: 9081914
• MDR Text Key: 159280343
• Report Number: MW5089843
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/13/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 0019F07G
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 43 YR
• Patient Weight: 111