MAUDE Adverse Event Report: APOLLO ENDOSURGERY LAPBAND

Device Problems Device Slipped (1584); Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 02/22/2010

Event Type  Injury  

Event Description

I have the lapband from (b)(6) and it's a recall i believe that's still in me.It's been a nightmare.I feel like an experiment.I'm so sick every day.Please help me.Went to a different doctor about my band is slipped and they put it in wrong it's flipped over and sometimes the pain is out of control, and i can't stand up straight at times.Reason for use: weight loss.

• Brand Name: LAPBAND
• Type of Device: LAPBAND
• Manufacturer (Section D): APOLLO ENDOSURGERY; apple valley CA 92307
• MDR Report Key: 6427971
• MDR Text Key: 70804409
• Report Number: MW5068610
• Device Sequence Number: 0
• Product Code: LTI
• 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: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/22/2010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 39 YR
• Patient Weight: 77