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

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Device implant date unknown.Explant date is (b)(6) 2021.Surgeon couldn't adjust it as the structure stiffened over time.

• 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 ; 9494817801
• MDR Report Key: 11844983
• MDR Text Key: 251527027
• Report Number: 3013508647-2021-00017
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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