MAUDE Adverse Event Report: JOHNSON & JOHNSON / ETHICON ENDO-SURGERY REALIZE BAND 10CC; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Model Number UNSURE

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Vomiting (2144); Cramp(s) (2193)

Event Date 11/30/2018

Event Type  Injury  

Event Description

I had a lapband for almost 10 years.I suffered from complications of the lapband for almost 8 of those years.Complications included pain at my port, excruciating cramps at my port, inability to perform abdominal exercises due to my port, inability to vomit(ie during stomach bug), painful hiccups, inability to burp, inability to eat many dense foods even when my band was empty.All of these things happened both while my band was filled and empty.I had no choice but to live with these side effects and complications because my insurance would not cover removal.Finally i was able to pay for removal myself.

• Brand Name: REALIZE BAND 10CC
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): JOHNSON & JOHNSON / ETHICON ENDO-SURGERY
• MDR Report Key: 8164586
• MDR Text Key: 130632892
• Report Number: MW5082123
• 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: 12/11/2018

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
• Device Model Number: UNSURE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 34 YR
• Patient Weight: 114