MAUDE Adverse Event Report: APOLLO ENDOSURGERY COSTA RICA S.R.L. LAP-BAND; IMPLANT, INTROGASTRIC FOR MORBID OBESITY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Vomiting (2144); Hernia (2240)

Event Type  Injury  

Event Description

Had lap-band weight loss surgery on (b)(6) 2008.Never reached desired restriction, band always seemed too tight, even when all fluid was completely removed.Experienced food getting stuck frequently (several times a day some days) when trying to eat, resulting in pain and frequent vomiting for 11 years before; i finally had it surgically removed on (b)(6) 2019.Also developed hernia following surgery in area where port was located.Fda safety report id# (b)(4).

• Brand Name: LAP-BAND
• Type of Device: IMPLANT, INTROGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY COSTA RICA S.R.L.
• MDR Report Key: 9172504
• MDR Text Key: 161804696
• Report Number: MW5090295
• 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: 10/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 41 YR
• Patient Weight: 114