MAUDE Adverse Event Report: APOLLO ENDOSURGERY ALLERGAN APL LAP BAND

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Burning Sensation (2146); Discomfort (2330)

Event Date 01/28/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, pt reported a burn on her skin over the area of lap band port after an mri exam completed on (b)(6) 2014.Location of burn: directly over lap band port (rlq) size of burn: pencil eraser descriptive report: pt states she felt a "burning" sensation at the port site during her mri performed (b)(6) 2014.2-3 hrs later, she felt a tenderness at the same area and when she checked the site it was blistered.It resolved in 2 days.Pt did not seek medical intervention.Pt did not report burn to our facility until (b)(6) 2014.Device implant surgery was in 2010.The port was last accessed during the first half of 2012.Pt could not be more specific.

• Brand Name: ALLERGAN APL LAP BAND
• Type of Device: LAP BAND
• Manufacturer (Section D): APOLLO ENDOSURGERY
• MDR Report Key: 4222441
• MDR Text Key: 16780658
• Report Number: MW5038914
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2014

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: 10/29/2014
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 120