MAUDE Adverse Event Report: APOLLO ENDOSURGERY INC. LAPBAND

Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Erosion (1750)

Event Date 02/27/2018

Event Type  Injury  

Event Description

I had to have my laparoscopic band removed due to slippage of the band around my stomach, erosion, and my surgical port becoming detached and was lodged under my rib.

• Brand Name: LAPBAND
• Type of Device: LAPBAND
• Manufacturer (Section D): APOLLO ENDOSURGERY INC.
• MDR Report Key: 7714336
• MDR Text Key: 114992575
• Report Number: MW5078553
• 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: 07/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 32 YR
• Patient Weight: 91