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

Catalog Number B-20360

Device Problem Material Disintegration (1177)

Patient Problem Abdominal Pain (1685)

Event Date 08/31/2023

Event Type  Injury  

Event Description

Complaint provided by emergo australia: patient attended emergency with acute progressive abdominal pain.Foreign body evident on stand surgery to remove the foreign material found to be a part of the lap-band system.Which had caused significant pain due to the foreign body causing irritation.Laparoscopic removal of lap band on (b)(6) 2020.

Manufacturer Narrative

The investigation was performed by iris.The letter with the investigation summary was sent to reshape on november 27, 2023.No further investigation was require to be conducted by us.The lhr couldn't be reviewed because is not available.The tga conducts a review of all adverse event reports received.The outcome may result in the commencement of a formal investigation which could lead to regulatory action such as the recall of the product, advice to users on the safe use of the device, manufacturing improvements and/or design changes.Reports not investigated are used for monitoring and trending analysis.This means that the information is incorporated into an ongoing body of evidence on the current real world performance and safety profile of the device.No further action to be taken unless more information is provided.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 18 technology drive, suite 110; irvine CA 92618
• Manufacturer (Section G): RESHAPE LIFESCIENCES; 18 technology drive, suite 110; irvine CA 92618
• Manufacturer Contact: maria quiroz ; 18 technology drive, suite 110; irvine, CA 92618 ; 8449377374
• MDR Report Key: 18339967
• MDR Text Key: 330667653
• Report Number: 3013508647-2023-00608
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/15/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: B-20360
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/15/2023
• 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
• Patient Sex: Female