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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Abdominal Pain (1685)

Event Type  Injury  

Manufacturer Narrative

No information available regarding the product that was involved.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.This information was posted on social media and attempts to contact the poster to follow-up or obtain additional information went unanswered 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.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.If additional information would be 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

Complainant alleged that their lap band failed because as they lost weight, the port flipped, causing extreme pain, which resulted in surgery to have the lap band removed.No other information was provided.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• Manufacturer (Section G): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92763
• Manufacturer Contact: brian stowe ; 1001 calle amanecer; san clemente, CA 92763 ; 8449377374
• MDR Report Key: 16591136
• MDR Text Key: 311762893
• Report Number: 3013508647-2023-00136
• 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: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2022
• 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