MAUDE Adverse Event Report: LAP BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); Ulcer (2274); Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 06/02/2017

Event Type  Injury  

Event Description

I had lap band placed in 2004.I had to have urgent removal due to obstruction, unable to tolerate foods, uncomfortable pain and tilted lap band.I have esophageal damage and esophageal ulcers from constant reflux.I had intolerable pain for 2 months around port and left side rib pain (surgery to remove the lap band alleviated the pain).

• Brand Name: LAP BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• MDR Report Key: 6801017
• MDR Text Key: 83049363
• Report Number: MW5071651
• 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: 08/15/2017

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Weight: 102