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

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Event Description

(b)(6) post received through marketing partner: patient stated: "mine was good for 8yrs.It flipped/twisted on my stomach and caused a small tear.Had emergency surgery to get it removed.I really enjoyed mine; gained (b)(6) lbs back.Had to wait 4yrs just to make sure stomach healed properly.Now trying to lose (b)(6) lbs for insurance to approve me for sleeve." no further information available from physician or patient.

• Brand Name: LAP-BAND SYSTEM
• Type of Device: ADJUSTABLE GASTRIC BAND
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 1001 calle amanecer; san clemente CA 92673
• MDR Report Key: 12652502
• MDR Text Key: 281207529
• Report Number: 3013508647-2021-00041
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• PMA/PMN Number: P000008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial
• Report Date: 10/18/2021

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
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention