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

Device Problem Device Slipped (1584)

Patient Problems Erosion (1750); Fatigue (1849); Hair Loss (1877); Unspecified Infection (1930); Nausea (1970); Pain (1994); Decreased Appetite (4569)

Event Date 04/01/2008

Event Type  Injury  

Event Description

Patient stated on social media that the {unspecified} surgery almost killed him/her on (b)(6) 2023.Additional social media comment posted later by same person ((b)(6)2023) stated the band was placed (b)(6) 2007, and in same port said that about 4 months later experienced nausea and pain, no appetite, hair loss and extreme fatigue.This occured until late (b)(6) 2008.The patient in same post reported an abscess at the port site that required draining and antibiotics, and that device was removed after an endoscope showed the device had slipped and caused erosion of the stomach.Infection continued until (b)(6) 2009.No other relevant information provided.

Manufacturer Narrative

This information was posted on social media and attempts to contact the poster to follow-up or obtain additional information were unsuccessful 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.No information is available regarding the product that was involved, the authenticity of the complainant, or the veracity of the information provided by the complainant.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 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 becomes available for investigation in the future, a supplemental report would be made.At this time, the reported issue will be tracked and trended.

• 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: brian stowe ; 1001 calle amanener; san clemente, CA 92673 ; 8779377374
• MDR Report Key: 16682313
• MDR Text Key: 312698250
• Report Number: 3013508647-2023-00181
• 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: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• 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: 03/13/2023
• 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; Other; Life Threatening