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

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

No information available regarding the product that was involved, the authenticity of the complainant, or the veracity of the information provided by the complainant.Multiple attempts to obtain additional information were unsuccessful.The company cannot verify the report and was unable to conduct further investigation due to the limited information that was provided in the post.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 could not be reviewed as the lot number was not provided.Unable to determine root cause.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Out of an abundance of caution and a desire for strict compliance, the company is reporting the limited information that was provided.If additional information becomes available for investigation in the future, a supplemental report would be made.At this time, the reported issue will be tracked and trended.

Event Description

Complaint received from social media: " it got corroded infected and put a hole in my stomach." "i had to go to (b)(6) to have it taken care of".No other relevant information was 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: 18903982
• MDR Text Key: 337663045
• Report Number: 3013508647-2024-00040
• 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,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• 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