MAUDE Adverse Event Report: RESHAPE LIFESCIENCES LAP-BAND SYSTEM; ADJUSTABLE GASTRIC BAND

Device Problem Insufficient Information (3190)

Patient Problems Autoimmune Disorder (1732); Dysphagia/ Odynophagia (1815); Vomiting (2144)

Event Type  malfunction  

Manufacturer Narrative

No investigation was performed.No information available regarding the product that was involved.Patient did not provide information for an investigation.Unable to determine if the complaint is about the lap-band or about another band which was available in the us and phased out at the end of 2016.Unable to determine root cause or conduct trending analysis.No further action to be taken unless the patient responds with more information.No new risks identified, the current risk is identified with a low rate of occurrence for the reported complaint categories.No correction or corrective action required.The lot history record for the complaint was not available to be reviewed.Unable to determine root cause.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.This information was posted on facebook and attempts to contact the poster to follow-up or obtain additional information were unsuccessful and thus, the company cannot verify the report and was unable to conduct further investigation due to the limited information that was provided in the post.Out of an abundance of caution and a desire for strict compliance, the company is reporting the limited information that was provided, as is.

Event Description

Facebook complaint received: "don't do it.Mine malfunctioned after 11 years, and my body rejected it.It grew a rind around itself and (think like a rind of cheese), the rind had to be cut off before they could even surgically remove the band.I also have several autoimmune disorders that are directly (caused by) lapband related.I threw up almost daily for a decade by way of basically forced bulimia, couldn't get even the tiniest nibble of food down (didn't matter what it was really!).Don't do it.A lot of surgeons have actually stopped offering this as an option because it's so bad." patient posted again after the third attempt: "don't do it.Mine was great.At first.Got it in 07.But when it malfunctioned it was hell.I couldn't keep anything down for over a year and literally survived on ice cream.If you move across the country and have to find a new doc? good luck with that as a lot of docs won't see someone who had the surgery done by another surgeon even if your reasons are legit like mine was.Nothing was showing up on any of the tests - it all appeared to be normal but it definitely was not.Turns out my body rejected my band after a decade and tried to eject it by growing a rind around it that didn't show up on any tests.It was basically choking my band and me.It took twice the amt of time to do the removal surgery because they didn't know the rind was there and had to cut it off before they could even get to the band.I had an option of revising to sleeve but i said no more surgeries.I'm ok with my body.It also caused several autoimmune disorders (directly related), i have dysphagia, and i have to get checked every year to make sure i don't develop barretts esophagus.Dont do it.".

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• Manufacturer Contact: maria quiroz ; 1001 calle amanecer; san clemente, CA 92673 ; 8449377374
• MDR Report Key: 15678031
• MDR Text Key: 305096467
• Report Number: 3013508647-2022-00211
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/26/2022

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: 09/26/2022
• Initial Date FDA Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention