MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. REALIZE GASTRIC BANDING; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problem Nonstandard Device (1420)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/12/2008

Event Type  Injury  

Event Description

"medically bulimic from gastr"; i had realized gastric banding placed (b)(6) 2008 from then until now i have had a very rough hard life there is a recall on it that i just found out about i need help.Fda safety report id# (b)(4).

• Brand Name: REALIZE GASTRIC BANDING
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.
• MDR Report Key: 10343660
• MDR Text Key: 201194936
• Report Number: MW5095788
• Device Sequence Number: 1
• Product Code: LTI
• 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
• Type of Report: Initial
• Report Date: 07/27/2020

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 18 YR
• Patient Weight: 98