MAUDE Adverse Event Report: INAMED LAP-BAND

Device Problems Device Slipped (1584); Aspiration Issue (2883)

Patient Problem Pain (1994)

Event Date 04/28/2015

Event Type  Injury  

Event Description

The lap-band slipped and was causing night aspiration.The port caused constant pain at the site.

• Brand Name: LAP-BAND
• Type of Device: LAP-BAND
• Manufacturer (Section D): INAMED
• MDR Report Key: 4866253
• MDR Text Key: 19744614
• Report Number: MW5043198
• 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: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Treatment: FERROUS SULFATE; MULTI VITAMIN; LEXAPRO
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 107