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

Device Problem Break (1069)

Patient Problems Erosion (1750); Hair Loss (1877); Sepsis (2067); Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

Attempts to contact the physician for additional information were made; however, no response was received from the physician.No information available regarding the product that was involved.Multiple attempts to obtain additional information for an investigation were unsuccessful.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 the lap band's port was severed and lap band had eroded patient's stomach.When it was discovered that the gastric band's port was severed, the patient received a surgery to remove the gastric band.The surgeon found the gastric band had eroded a hole into the patient's stomach.The gastric band was removed.The expected 2 hours surgery was extended to 8 hours.The patient remained in the hospital for 2 weeks after the surgery.During this time, the patient experienced sepsis and was given strong antibiotic, which caused her hair loss.The patient also complained of difficulty with breathing.It was found that fluid was built up around the lung causing it to collapse completely.The patient also complained of developing hernia which required surgery.

• 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: 15969524
• MDR Text Key: 305361080
• Report Number: 3013508647-2022-00282
• 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: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Date Manufacturer Received: 11/17/2022
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female