MAUDE Adverse Event Report: JOHNSON AND JOHNSON REALIZE BAND

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Complaint, Ill-Defined (2331)

Event Date 12/05/2013

Event Type  Injury  

Event Description

In (b)(6) of 2013 i started experiencing extreme abdominal distress.After multiple visits to the emergency room, 3 upper gi scopes, and countless other tests and medications, it was determined that my johnson and johnson realize band (adjustable gastric band) was causing severe complications that required immediate surgery for removal.I met with a general surgeon on (b)(6) 2013 and my band was removed on (b)(6) 2013.

• Brand Name: REALIZE BAND
• Type of Device: REALIZE BAND
• Manufacturer (Section D): JOHNSON AND JOHNSON
• MDR Report Key: 4916303
• MDR Text Key: 6051576
• Report Number: MW5044166
• Device Sequence Number: 1
• Product Code: LTI
• 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: 07/07/2015

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: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2015
• Patient Sequence Number: 1
• Treatment: RX MEDS: METFORMIN (PCOS)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 30 YR
• Patient Weight: 137