MAUDE Adverse Event Report: JOHNSON AND JOHNSON / ETHICON ENDO-SURGERY LAP BAND

Device Problem Device Slipped (1584)

Patient Problems Aspiration/Inhalation (1725); Vomiting (2144); Choking (2464)

Event Date 04/01/2017

Event Type  Injury  

Event Description

Major band slip.Couldn't eat or drink for weeks.Was only able to sip clear liquids here and there, only able to keep down maybe 4 oz a day of liquid.Choking and aspirating on vomit in my sleep.

• Brand Name: LAP BAND
• Type of Device: LAP BAND
• Manufacturer (Section D): JOHNSON AND JOHNSON / ETHICON ENDO-SURGERY
• MDR Report Key: 7714084
• MDR Text Key: 115028850
• Report Number: MW5078534
• Device Sequence Number: 0
• 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: 07/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 34 YR
• Patient Weight: 63