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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Insufficient Information (4580)

Event Type  Injury  

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 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.

Event Description

(b)(6) complaint received: "it was the worst thing i ever did!! recovering now from having it removed! i have esophageal dysplasia and massive adhesions!! do the sleeve in stead!! i had my band for over 11 years.Most people end up having them removed!! please do your research!!.

• 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: 15058207
• MDR Text Key: 296209022
• Report Number: 3013508647-2022-00051
• 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: 07/19/2022

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 Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/19/2022
• 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): Other; Required Intervention