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 Arthritis (1723); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Vomiting (2144)

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.Implant date, only year was provided.

Event Description

It was reported by the patient that the patient developed health issues and digestion issues while having the gastric band.The patient got the gastric band implanted in 2011.Per report, everything went great and the patient lost 150 lbs fast, but the patient lost the teeth because of puking.The patient complained of trapping gas more frequent than before receiving the gastric band.The patient had hemorrhoids, nausea and sliming due to bad allergies.The patient also believed that the physician chose the band size too small and it was tightened too tight.The patient had the band unfilled by a new doctor as the original treating doctor passed away.After the unfill, the patient reported to feel better but still having digestion issues.The patient reported of not getting proper nutrition, having issue with certain meat/proteins, regained weight and developed osteoarthritis.

• 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: 15847773
• MDR Text Key: 304174378
• Report Number: 3013508647-2022-00275
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: 10/30/2022
• Initial Date FDA Received: 11/22/2022
• 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