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

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

Attempts to contact the patient for additional information were made; however, no response was received from the patient.No information available regarding the product that was involved.The patient 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 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 for review.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

It was reported by the patient that patient experienced pain while having the gastric band.Per report, the patient was leaning over before hearing a pop.The patient went on for 3 months before receiving surgery.The patient complained of bad pain.It was discovered that the patient had an 2 inches hole in the stomach above the gastric band.The 45 minutes surgery was extended to 5 hours 30 minutes surgery.Per patient, the bodily fluid did not come out through the hole because the gastric band was tight.The patient was having feeding tube for 6 weeks after the surgery.A drain tube was also used.

• 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: toan hoang ; 1001 calle amanecer; san clemente, CA 92673 ; 9492764349
• MDR Report Key: 15844697
• MDR Text Key: 304118431
• Report Number: 3013508647-2022-00268
• 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: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Date Manufacturer Received: 10/23/2022
• 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): Other; Required Intervention; Hospitalization