MAUDE Adverse Event Report: JOHNSON AND JOHNSON / ETHICON ENDO-SURGERY, INC ETHICON GASTRIC BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problem Device Slipped (1584)

Patient Problem Vomiting (2144)

Event Date 01/04/2020

Event Type  Injury  

Event Description

I have an ethicon gastric band, i have had 3 band slips, the slip in april i had to go to the emergency department of my local hospital, i had the band emptied but.It has caused damage, i get trapped food which causes me to vomit, i am currently waiting to get this ethicon band removed.Please could you let me know if there are any issues with this particular gastric band, ethicon.Fda safety report id# (b)(4).

• Brand Name: ETHICON GASTRIC BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): JOHNSON AND JOHNSON / ETHICON ENDO-SURGERY, INC; 4545 creek rd; cincinnati OH 45242
• MDR Report Key: 11064805
• MDR Text Key: 223608746
• Report Number: MW5098495
• Device Sequence Number: 1
• Product Code: LTI
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/19/2020

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: 12/22/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR