MAUDE Adverse Event Report: LAP BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Patient Problems Failure of Implant (1924); Sepsis (2067); Vomiting (2144); Convulsion/Seizure (4406); Unspecified Gastrointestinal Problem (4491)

Event Date 09/24/2022

Event Type  Injury  

Event Description

My lap band wore out was in hospitals in and out for a year on my birthday i had seized all day.In hospital had 6 surgeries back to back.Lap band removed, 7pints of blood replaced i was septic, left colon removed, 3 feet of intestine's left.Stomach cut, colon bag to pop in, iv fluids only feeding tube only, trach in throat, for 3 months tied to bed last surgery was (b)(6) 2023 reattached colon and took off colon bag.Reattached intestines.Should have died drs said i was very strong.Went threw trauma after trauma for this product.Never worked right.Always throwing up.Thank god every thing works normal.Lost 80 pounds and hair threw this 3 months.

• Brand Name: LAP BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• MDR Report Key: 17390078
• MDR Text Key: 319828333
• Report Number: MW5120005
• 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: 07/19/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2023
• Patient Sequence Number: 1
• Treatment: FISH OIL; KLONOPIN 1MG; MAGNESIUM; ONE DAY VITAMIN 50PLUS; SEROQUEL 200MG; TART CHERRY 101; VITAMIN C ; VITAMIN D 3; WELLBUTRIN XR 150MG
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening; Other
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White