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

Catalog Number 31558-2806

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Sepsis (2067)

Event Type  Injury  

Manufacturer Narrative

No investigation was performed.No information available regarding the product that was involved.Surgeon 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 surgeon 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.Note: 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 unless you get scooped 1 time a year almost died.Erosion does not show on xrays.Had lap band for 5 years.Had to have emergency surgery/ removal after severed stomach.Had sepsis spent 9 days in icu.Almost died".

• 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: 15654359
• MDR Text Key: 302250625
• Report Number: 3013508647-2022-00203
• 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: 10/21/2022

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?: No
• Device Catalogue Number: 31558-2806
• Device Lot Number: 31558-2806
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/21/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female