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 Vomiting (2144); Cancer (3262); Implant Pain (4561)

Event Type  Injury  

Event Description

(b)(6) complaint received: "i developed stomach cancer behind my procedure for over 2 years i was deathly sick throwing up feeling like it was dying i have been doing chemo but it took so much out of me with lupus,diabetes, high blood pressure,total nerve damage neck down 4 surgeries.Did radiation felt like my insides were frying i honestly had scaly dry terrible skin nothing i use helps with the dryness.I just want people to research before they do surgery i lost 56 lbs before surgery after surgery i ate thingz size of silver dollar and throw it up.I would rather not i signed papers and i did contact an attorney he said i couldn't do anything so now i live a very boring life consist of watching tv, take my dog short walks there is days i hurt to bad i can't get out of bed alot of times if i carry 12 pack soda i feel like im going to rip apart.I lost weight but i lost me to i was very outgoing now i do good walk in store i get so tired alot of times if long lines i say forget it.".

Manufacturer Narrative

No investigation was performed.No information available regarding the product that was involved.Patient did not want to provide any information or be contacted further.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 in cpr0001 rev d.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.

• 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: minh guong nguyen ; 1001 calle amanecer; san clemente, CA 92673 ; 8449377374
• MDR Report Key: 14676359
• MDR Text Key: 293928618
• Report Number: 3013508647-2022-00030
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/07/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/13/2022
• 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