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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Vomiting (2144); Weakness (2145); No Code Available (3191)

Event Type  Injury  

Event Description

Lap band had to be removed.I was vomiting nightly and at the end very little food was getting down making me weak and emaciated.Fda safety report id# (b)(4).

• Brand Name: LAP BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.
• MDR Report Key: 8964922
• MDR Text Key: 156761712
• Report Number: MW5089553
• 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): Required Intervention
• Patient Weight: 104