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

Model Number B-2240

Device Problem Mechanical Problem (1384)

Patient Problems Erosion (1750); Pain (1994); Sepsis (2067)

Event Date 01/02/2022

Event Type  Injury  

Manufacturer Narrative

Waiting for additional information from the surgeon who has been providing care for the patient.

Event Description

Patient reported emergency removal of lap-band and that explanted band was green with algae.She stated that there was no fluid in the band, and that it had eroded two layers of her stomach and caused her to be septic.Patient reported going to hospital er over a two year span.In that span of time had chest pain and gallbladder removed.

Manufacturer Narrative

Attempts to contact the medical professionals involved in the care of the complainant to obtain information were refused or were unsuccessful and thus, the company was unable to conduct further investigation due to the limited information that was.Out of an abundance of caution and a desire for strict compliance, the company is reporting the limited information that was provided, as is.Unable to determine root cause or conduct trending analysis.No further action to be taken unless more information becomes available.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 will be made.At this time, the reported issue will be tracked and trended.

Event Description

Patient reported emergency removal of lap-band and that explanted band was green with algae.She stated that there was no fluid in the band, and that it had eroded two layers of her stomach and caused her to be septic.Patient reported going to hospital er over a two year span.In that span of time had chest pain and gallbladder removed.Additional information provided after submission of initial report on 30mar23: had to go home from hospital with a picc line.Patient provided names of 3 doctors that provide(d) care.Two of the three doctors were unwilling to provide any further information and the third has not been reached as of the date of this follow up report.

• 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 amanecer; san clemente, CA 92673 ; 8449377374
• MDR Report Key: 16645993
• MDR Text Key: 312346921
• Report Number: 3013508647-2023-00194
• 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,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: B-2240
• Device Catalogue Number: B-2240
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2023
• 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; Life Threatening; Hospitalization; Other
• Patient Age: 43 YR
• Patient Sex: Female