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

Lot Number LOT 17 D17G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/24/2017

Event Type  Injury  

Event Description

Patient received a single hyaluronic injection in her right knee and developed necrotizing pancreatitis within 48 hours.In icu for 7 days and inpatient for additional 14.Zimmer biomet.

• Brand Name: GEL ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION TAKAHAGI PLANT
• MDR Report Key: 9641584
• MDR Text Key: 177024532
• Report Number: MW5092572
• 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: Physician
• Type of Report: Initial
• Report Date: 01/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/30/2018
• Device Lot Number: LOT 17 D17G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 55 YR
• Patient Weight: 85