MAUDE Adverse Event Report: APPOLO ENDOSURGERY, INC. LAP BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problem Material Erosion (1214)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2019

Event Type  Injury  

Event Description

Lap band removed for having eroded in my stomach.Fda safety report id# (b)(4).

• Brand Name: LAP BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APPOLO ENDOSURGERY, INC.
• MDR Report Key: 8964942
• MDR Text Key: 156761768
• Report Number: MW5089554
• 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: 09/02/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Weight: 126