MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. REALIZE ADJ GASTRIC BAND STR; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZB22

Device Problem Patient-Device Incompatibility (2682)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.The exact date of device implant and removal was not provided.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.

Event Description

It was reported that, post implant of gastric lap band in 2006; there were many days where patient would vomit anything patient tried to eat.Reflux started a few years in.Went on rx meds.Dentist said patient's teeth are damaged from reflux and vomiting.Patient has almost constant body aches, especially left shoulder and right side where port was attached.Patient had x-rays, barium swallows, ct scan, ultrasound, hida scan, and it all pointed back to the lap band.Removal surgery was in 2019 and aches are gone, reflux is finally under control.Patient hopes that there is no lasting damage now that this thing is out of patient's body.

• Brand Name: REALIZE ADJ GASTRIC BAND STR
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8962565
• MDR Text Key: 156568672
• Report Number: 3005075853-2019-21665
• 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: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/27/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: RLZB22
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other