MAUDE Adverse Event Report: APOLLO ENDOSURGERY INC. ADJUSTABLE GASTRIC BAND LAP BAND; IMPLANT INTRAGASTRIC FOR MORBID OBESITY

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

Patient Problems Abdominal Pain (1685); Anemia (1706); Fatigue (1849); Vomiting (2144); Injury (2348); Abdominal Cramps (2543); Abdominal Distention (2601); Constipation (3274)

Event Date 09/13/2018

Event Type  Injury  

Event Description

Had a laparoscopic band placed in (b)(6) 2018.Have had my health problems since, vomiting, acid reflux, constipation, fatigue, vitamin deficiency, anemia, slippage, stomach issues as ion pain and cramps, bloating, and damaged esophagus.

• Brand Name: ADJUSTABLE GASTRIC BAND LAP BAND
• Type of Device: IMPLANT INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY INC.
• MDR Report Key: 7926066
• MDR Text Key: 122630787
• Report Number: MW5080254
• 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: 09/28/2018

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 44 YR
• Patient Weight: 93