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

Device Problem Migration (4003)

Patient Problems Anemia (1706); Erosion (1750); Pain (1994); Tachycardia (2095); Hematemesis (4478); Melena (4480)

Event Date 06/03/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing, and as additional information becomes available, a supplemental report will be made.At this time, the reported issue will be tracked and trended.Implant date: literature author stated the device was implanted 10 years ago but didn't specify the exact date.

Event Description

Literature review performed.A rare case of an incidental near-complete gastric band erosion without perforation wong v, choi c, qiu h, et al.(june 03, 2022) a rare case of an incidental near-complete gastric band erosion without perforation.Cureus 14(6): e25636.Doi 10.7759/cureus.25636.A 62-year-old female with a history of a laparoscopic gastric band placed ten years ago who experienced band removal due to band erosion.

• 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: jazmin quiroz ; 1001 calle amanener; san clemente, CA 92673 ; 8779377374
• MDR Report Key: 16834557
• MDR Text Key: 314262204
• Report Number: 3013508647-2023-00275
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2023

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/28/2023
• 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; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female